This page shows what was measured, who it was measured in, and what that does not settle.
What Aldesleukin does in the body
Metastatic renal cell carcinoma
From the FDA-approved label: Aldesleukin is an interleukin-2 lymphocyte growth factor. The antitumor activity of aldesleukin has not been fully characterized. In vitro studies performed on human cell lines show enhancement of lymphocyte mitogenesis and cytotoxicity, induction of killer cell activity [lymphokine-activated killer (LAK) and natural killer (NK) cells] and interferon gamma production, and proliferation of human interleukin-2-dependent cell lines. Administration of aldesleukin in animals and humans produces multiple immunological effects in a dose-dependent manner.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · M89N0Q7EQR · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 92 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Recovery
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Recovery
time to marrow recovery
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
New or Recurrent HIV Disease Progression Event Including Death
✗ The study did not show it
Who was studied
NCT00004978
How many people
4150
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Event Free Survival (R1: MAT therapy)
✗ The study did not show it
Who was studied
NCT01704716
How many people
3300
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Duration of overall survival and disease-free survival after first randomization
✗ The study did not show it
Who was studied
NCT00004128
How many people
2000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
New or Recurrent Disease Progression Events, as Defined, or Death.
✗ The study did not show it
Who was studied
NCT00013611
How many people
1695
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Event-Free Survival (EFS)
✗ The study did not show it
Who was studied
NCT00026312
How many people
1449
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Objective Response (OR)
✗ The study did not show it
Who was studied
NCT00338377
How many people
1230
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.10 registered measures of this kind. 5 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
overall survival
disease free survival
complete remission at the end of consolidation therapy
survival following consolidation
event free survival following consolidation
event free survival
relapse rate for lymphoma after autologous transplant
time to disease progression
overall survival and progression free survival
survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (30)
cd4 count
response rate
immune response
dying or residual disease during induction therapy
time to marrow recovery
frequency of toxicities including infectious complications
marrow status
blasts
clinical response rate
toxicity assessed using common toxicity criteria version 2 0
best response rate
toxicity
maximum tolerated dose
toxicity profile
clinical responses
overall response
clinical tumor regression
response
safety
tumor regression
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) The treatment of adults with metastatic melanoma. ( 1.2 ) 1.1 Metastatic Renal Cell Carcinoma Proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (RCC). 1.2 Metastatic Melanoma Proleukin is indicated for the treatment of adults with metastatic melanoma.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of Proleukin have not been established in pediatric patients.”
US prescribing information · f3c516ad-d405-4fbe-af6a-962080dbfa7d · read 2026-08-30
On older people, the label states: “Clinical studies of Proleukin did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.”
US prescribing information · f3c516ad-d405-4fbe-af6a-962080dbfa7d · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings in an animal study and its mechanism of action, Proleukin may cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1) ].”
US prescribing information · f3c516ad-d405-4fbe-af6a-962080dbfa7d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of aldesleukin in either human or animal milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · f3c516ad-d405-4fbe-af6a-962080dbfa7d · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S3, S6.
No source is stored against this line.
What is in the pack
Sold as vial, pellet, solution/ drops, injection, powder, lyophilized, for solution, given by the oral, intravenous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Aldesleukin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 430 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
hypotension — 72 reaction mentions
pyrexia — 60 reaction mentions
diarrhoea — 53 reaction mentions
vomiting — 42 reaction mentions
thrombocytopenia — 41 reaction mentions
dehydration — 38 reaction mentions
chills — 35 reaction mentions
anaemia — 30 reaction mentions
tachycardia — 30 reaction mentions
disease progression — 29 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
9 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 17089-295 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, pellet, powder and solution/ drops, taken intravenous and oral.
FDA National Drug Code directory · 17089-295 · read 2026-08-29
The regulator's established pharmacologic class for it is increased lymphocyte activation [pe], increased lymphocyte cell production [pe] and interleukin-2 [cs].
FDA National Drug Code directory · 17089-295 · read 2026-08-29
7 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 4a5714f9-e0ab-41b2-b214-fed33c807358 · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 4a5714f9-e0ab-41b2-b214-fed33c807358 · read 2026-08-29
PROLEUKIN is intravenous at 3 DOSAGE FORMS AND STRENGTHS For Injection: 22 million International Units (1.3 mg) of aldesleukin available as a white to off-white, lyophilized powder in a single-dose vial for reconstitution., recorded as fda label in effect 2024-12-20 in the United States.
US prescribing information · f3c516ad-d405-4fbe-af6a-962080dbfa7d · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Aldesleukin studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Aldesleukin are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
M89N0Q7EQR
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S3, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
1 approved application covers products containing this substance. The earliest was BLA103293, approved 19920505 to CHIRON.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (9)
Q2
What did Aldesleukin's largest trial (4150 people) and its longest (25 years) measure?
4150 people in Aldesleukin's largest registered study, 25 years in its longest registered window, measuring The primary endpoint of the study is feasibility and safety of the autologous HSCT and low dose IL-2 post-HSCT, as evaluated by day +100 TRM (transplant related mortality) and incidence of severe… ClinicalTrials.gov · 2026-09-01
256 phase2, 196 phase1, 33 phase3, 10 na, 7 early phase1, 6 phase4, 5 na or unstated; NCT00534469; 2025-07-16; no ageing endpoint recorded. Last human test completed 2026, NCT04426669.
Interpretation These counts include studies where Aldesleukin was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
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phase2
256
phase1
196
phase3
33
na
10
early phase1
7
phase4
6
2 more recorded rows
na or unstated
5
Last recorded human testNCT04426669
2026-01-22
recorded 2026-09-01 · last checked 2026-09-04
Q3
Aldesleukin was tested only in human — what did it show?
The primary endpoint of the study is feasibility and safety of the autologous HSCT and low dose IL-2 post-HSCT, as evaluated by day +100 TRM (transplant… — the recorded outcome words.
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humanNCT02676622
lifespan; The primary endpoint of the study is feasibility and safety of the autologous HSCT and low dose IL-2 post-HSCT, as evaluated by day +100 TRM (transplant related mortality) and incidence of severe toxicity.; 429
"Insufficient Accrual"; 85 of 429 registered studies
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Trial
NCT00003009
terminated; "Insufficient Accrual"
NCT00005788
terminated; "Low/inadequate rate of accrual."
NCT00006113
terminated; "Lack of efficacy"
NCT00022230
withdrawn; "PI left Institution"
NCT00052377
terminated; "Administratively complete."
NCT00054405
terminated; "Administratively complete."
14 further recorded trials
NCT00089778
terminated; "fewer tumors than expected expressed FGF-5, led to end of accrual to cohorts A\&B"
NCT00250861
terminated; "Study terminated due to lack of enrollment."
NCT00277758
terminated; "Insufficient rate of volunteer accrual."
NCT00354172
terminated; "Competing study was started."
NCT00485563
terminated; "Changes in treatment paradigm resulted in a lower than expected rate of accrual."
NCT00505635
terminated; "Slow accrual"
NCT00509496
terminated; "Low accrual"
NCT00569296
terminated; "Funding ended"
NCT00610311
terminated; "The study was terminated due to low accrual."
NCT00612222
terminated; "The study was terminated due to low accrual."
NCT00625729
terminated; "No patients exhibited natural killer cell expansion (primary endpoint)."
NCT00652899
terminated; "Withdrawn due to toxicity"
NCT00670748
terminated; "A more highly selected protocol with ESO TCR opened for pts with melanoma"
NCT00698009
terminated; "Slow accrual."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which of adverse events, anti tumor activity and best response rate did Aldesleukin's trials measure?
adverse events, anti tumor activity and best response rate lead 40 outcome terms across Aldesleukin's trials. ClinicalTrials.gov · 2026-09-01
Interpretation response rate, immune response, dying or residual disease during induction therapy, time to marrow recovery, frequency of toxicities including infectious complications and marrow status follow.
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cd4 count
1
overall survival
1
disease free survival
1
response rate
1
immune response
1
dying or residual disease during induction therapy
1
14 more recorded rows
time to marrow recovery
1
frequency of toxicities including infectious complications
1
marrow status
1
blasts
1
complete remission at the end of consolidation therapy
1
survival following consolidation
1
event free survival following consolidation
1
event free survival
1
relapse rate for lymphoma after autologous transplant
1
clinical response rate
1
toxicity assessed using common toxicity criteria version 2 0
1
time to disease progression
1
best response rate
1
toxicity
1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of Aldesleukin's 43 ongoing trials reports first?
Objective Response (OR); Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I; latest 2038-04
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Trial
NCT00338377
"Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma"; n 1230; "Objective Response (OR)"; 2030-02-28
NCT01038778
"Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer"; n 47; "Dose-limiting Toxicities of Entinostat When Combined With Aldesleukin Within the Phase I"; 2027-02-12
NCT01174121
"Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer"; n 332; "Response rate"; 2029-12-27
NCT01697527
"Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies"; n 6; "Clinical response"; 2027-11-02
NCT01704716
"High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)"; n 3300; "Event Free Survival (R1: MAT therapy)"; 2026-09
NCT01955460
"Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma"; n 34; "(Cohort A) Generation of TGF alpha (TGFa)-DNRII and NGFR transduced tumor infiltrating lymphocytes (TILs)"; 2027-10-30
14 further recorded trials
NCT02133196
"T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer"; n 85; "Response rate"; 2027-10-23
NCT02306954
"Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer"; n 84; "Response Rate"; 2026-12
NCT02621021
"A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab"; n 53; "Response rate"; 2029-06-16
NCT02830724
"Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers"; n 124; "Frequency and severity of treatment-related adverse events"; 2030-01-01
NCT03017131
"Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer"; n 9; "Incidence of adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4"; 2032-03-23
NCT03190941
"Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients"; n 110; "Response rate"; 2028-06-29
NCT03412877
"Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer"; n 285; "Response rate"; 2029-03-23
NCT03449108
"LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas"; n 30; "Objective response rate"; 2027-04-30
NCT03501381
"High Dose IL 2 and Entinostat in RCC"; n 46; "Progression Free Survival (PFS)"; 2024-04
NCT03782636
"Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)"; n 41; "Differences in slopes of DBS (Dried Blood Spot) C-peptide over the 6 month-treatment period between the active and placebo groups."; 2026-09
NCT04562129
"IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients"; n 29; "Response Rate"; 2029-11
NCT05141474
"Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors"; n 10; "Incidence of Adverse Events (AE)"; 2027-01-01
NCT05155033
"Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma"; n 78; "Response rate in treatment refractory disease"; 2031-09-01
NCT05267626
"Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer"; n 159; "Evaluate the safety and tolerability of AU-007"; 2027-02-28
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which running trial of Aldesleukin could settle lifespan?
NCT03501381 measures Progression Free Survival (PFS), reading out 2024-04.
2 open trials; n 46; "High Dose IL 2 and Entinostat in RCC"
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Trial
NCT03501381
"High Dose IL 2 and Entinostat in RCC"; n 46; "Progression Free Survival (PFS)"; 2024-04
NCT01704716
"High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)"; n 3300; "Event Free Survival (R1: MAT therapy)"; 2026-09
Q8
Which 148 trials of Aldesleukin posted no result?
Posted no result
148 of 148 completed trials
Registrations
NCT00000728, NCT00000680, NCT00000986, NCT00001005, NCT00002504 and NCT00000889, and 142 more
Completion dates
oldest 1990-04; newest 2023-12-31
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Trial
NCT00000728
1990-04
NCT00000680
1993-04
NCT00000986
1994-01
NCT00001005
1995-02
NCT00002504
1999-02
NCT00000889
1999-12
14 further recorded trials
NCT00002572
1999-12
NCT00002733
2000-01
NCT00003091
2000-01
NCT00003408
2000-03
NCT00003962
2000-06
NCT00000949
2000-07
NCT00002637
2001-02
NCT00000849
2001-03
NCT00004248
2001-05
NCT00005943
2001-09
NCT00005948
2001-10
NCT00000820
2002-03
NCT00000821
2002-03
NCT00003356
2002-05
Q9
At the median, Aldesleukin's trials enrolled 21 people — anything larger?
Median enrolment
21
Largest enrolment
4150
Registered trials counted
369
Q10
What do 430 spontaneous reports say about Aldesleukin — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Aldesleukin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 430 reaction mentions were counted: hypotension 72; pyrexia 60; diarrhoea 53; vomiting 42. open-targets-adr · CHEMBL1201438 · 2026-06-24
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hypotension
72
pyrexia
60
diarrhoea
53
vomiting
42
thrombocytopenia
41
dehydration
38
4 more recorded rows
chills
35
anaemia
30
tachycardia
30
disease progression
29
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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