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Ganirelix

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Ganirelix does in the body

At midcycle, a large increase in GnRH release results in an LH surge.

From the FDA-approved label: The pulsatile release of GnRH stimulates the synthesis and secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The frequency of LH pulses in the mid and late follicular phase is approximately 1 pulse per hour. These pulses can be detected as transient rises in serum LH. The midcycle LH surge initiates several physiologic actions including: ovulation, resumption of meiosis in the oocyte, and luteinization. Luteinization results in a rise in serum progesterone with an accompanying decrease in estradiol levels.

Why people take it. The inhibition of premature LH surges

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 chemical.

    FDA substance registry · IX503L9WN0 · read 2026-08-29

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

No statement of the main limit is recorded.

The four opening statements run to 114 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.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

What happened in peopleRead 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 31 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.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Fertility and sexual healthNothing 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.Only a number moved1 registered test measure.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
Fertility and sexual health
average blood testosterone concentration

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.
Only a number moved
1 registered test measure.
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 peopleRead 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.

Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)

The study did not show it

Who was studied
NCT00696800
How many people
1509
Study design
Phase 3
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. Injection

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Frequency of Ovarian Hyperstimulation Syndrome (OHSS)

The study did not show it

Who was studied
NCT00756028
How many people
1099
Study design
Phase 4
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. Injection

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Live birth rate

The study did not show it

Who was studied
NCT02912988
How many people
900
Study design
Phase 3
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. Injection

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

live birth rate

The study did not show it

Who was studied
NCT04414761
How many people
784
Study design
Phase 3
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. Injection

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Ongoing pregnancy rate after the first embryo transfer

The study did not show it

Who was studied
NCT05847283
How many people
730
Study design
Not applicable
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. Injection

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
  • PubChem PUG-REST · a recorded source, not a stored snapshot

The number of oocytes retrieved by the IVG 36 hours after hCG administration

The study did not show it

Who was studied
NCT03300518
How many people
552
Study design
Not applicable
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. Injection

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
  • PubChem PUG-REST · 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 peopleRead 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.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No 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 takeRead 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.

  • average blood cortisol concentration
  • average blood testosterone concentration
  • serum lh levels

Meaningful

Things that change how a life goes, not only a number.

No registered study measured anything of this kind.

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 (28)
  • oocytes retrieved for ivf
  • without premature luteinizing hormone surge
  • ongoing pregnancy rate per embryo transfer
  • development of ohss
  • pregnancy rates
  • endothelial function
  • an ongoing pregnancy
  • oocytes retrieved
  • mothers in current follow up trial experiencing serious aes
  • infants born in current follow up trial experiencing aes
  • infants in current follow up trial experiencing saes
  • pregnancy rate
  • ongoing pregnancy at week 8
  • orthostatic tolerance
  • baroreceptor function
  • skin microvascular responses
  • serious adverse events
  • endometrial thickness measured by ultrasound
  • cumulus oocyte complexes retrieved during oocyte pick up
  • ongoing pregnancy

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead 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.

  • Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

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 older people, the label states: “Clinical studies with Ganirelix Acetate Injection did not include a sufficient number of subjects aged 65 and over.”

    US prescribing information · 9c286f64-8039-44ec-8fdd-d1a2f52b4c3c · read 2026-08-30

  • On people who are pregnant, the label states: “Ganirelix Acetate Injection is contraindicated in pregnant women.”

    US prescribing information · 9c286f64-8039-44ec-8fdd-d1a2f52b4c3c · read 2026-08-30

  • On people who are breastfeeding, the label states: “Ganirelix Acetate Injection should not be used by lactating women.”

    US prescribing information · 9c286f64-8039-44ec-8fdd-d1a2f52b4c3c · 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 takeRead 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 takeRead 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

Injection

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: S1.

No source is stored against this line.

What is in the pack

Sold as injectable, injection, solution, injection, given by the injection, subcutaneous 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 takeNothing 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.

Ganirelix appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 793 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • ovarian hyperstimulation syndrome — 401 reaction mentions
  • ascites — 154 reaction mentions
  • dyspnoea — 48 reaction mentions
  • abdominal pain — 38 reaction mentions
  • pleural effusion — 37 reaction mentions
  • peritoneal haemorrhage — 26 reaction mentions
  • ovarian haemorrhage — 24 reaction mentions
  • premature ovulation — 24 reaction mentions
  • abortion spontaneous — 22 reaction mentions
  • abdominal distension — 19 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 unclearRead 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

Injection

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

  • 16 products list this as an active ingredient in the United States drug directory. 16 of them contain it and nothing else.

    FDA National Drug Code directory · 42973-325 · read 2026-08-29

  • They are sold as injection, injection, solution and powder, taken subcutaneous.

    FDA National Drug Code directory · 42973-325 · read 2026-08-29

  • The regulator's established pharmacologic class for it is decreased gnrh secretion [pe], gonadotropin releasing hormone receptor antagonist [epc] and gonadotropin releasing hormone receptor antagonists [moa].

    FDA National Drug Code directory · 42973-325 · read 2026-08-29

  • 10 published labels name it as an active ingredient. 10 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 1f067dfb-f9c7-4020-ab7b-da2ba695ab32 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 1f067dfb-f9c7-4020-ab7b-da2ba695ab32 · read 2026-08-29

  • Ganirelix Acetate is subcutaneous at HOW SUPPLIED Ganirelix Acetate Injection is supplied in: Disposable, ready for use, single dose, sterile, prefilled 1 mL glass syringes containing 250 mcg/0.5 mL aqueous solution of Ganirelix Acetate closed with a rubbe…, recorded as fda label in effect 2022-04-19 in the United States.

    US prescribing information · 9c286f64-8039-44ec-8fdd-d1a2f52b4c3c · 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 takeRead 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 Ganirelix 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 unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

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 Ganirelix 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 peopleRead 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.

How many documents were read

  • 10 documents were read for this substance.

    RNAWiki source record

  • 10 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
IX503L9WN0
CAS registry number
124904-93-4
PubChem compound
16130957
ChEMBL
CHEMBL1251
WHO international nonproprietary name list entry
6830
RxNorm concept
35825
EMA substance identifier
100000085437
DrugBank
DB06785

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: S1.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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

  • 8 approved applications cover products containing this substance. The earliest was NDA021057, approved 19990729 to ORGANON USA ORGANON.

    Drugs@FDA application register · NDA021057 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA021057 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20170901.

    FDA National Drug Code directory · 42973-325 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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

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Recorded evidence blocks (9)

What did Ganirelix's largest trial (2066 people) and its longest (9.1 years) measure?


2066 people in Ganirelix's largest registered study, 9.1 years in its longest registered window, measuring Average Blood Cortisol Concentration. ClinicalTrials.gov · 2026-09-01

20 phase4, 9 na, 9 phase3, 5 na or unstated, 4 early phase1, 4 phase2, 2 phase1; NCT03142893; 2026-06-30. Last human test completed 2025, NCT05954962.

Interpretation These counts include studies where Ganirelix 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.

Show the evidence
  • phase4
    20
  • na
    9
  • phase3
    9
  • na or unstated
    5
  • early phase1
    4
  • phase2
    4
2 more recorded rows
  • phase1
    2
  • Last recorded human test NCT05954962
    2025-08-30

recorded 2026-09-01 · last checked 2026-09-04

Ganirelix was tested only in human — what did it show?


human: biomarker (52): the rungs where Ganirelix has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Average Blood Cortisol Concentration — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT03142893
    biomarker; Average Blood Cortisol Concentration; 52

recorded 2026-09-01 · last checked 2026-09-04

4 of Ganirelix's trials stopped: accrual/recruitment, other?


accrual/recruitment (2) and other (2): Ganirelix's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Inclusion of the study didn't go as fast as expected. Expect: 234 patients in 1 year in 2 centers. After 1,5 year only 147 patients were recruited."; 4 of 52 registered studies

Show the evidence

Trial

  • NCT00823472
    terminated; "Inclusion of the study didn't go as fast as expected. Expect: 234 patients in 1 year in 2 centers. After 1,5 year only 147 patients were recruited."
  • NCT00826839
    withdrawn; "poor enrollment"
  • NCT00866008
    terminated; "Due to a very slow inclusion rate."
  • NCT01614067
    terminated; "Slow enrollment resulted in withdraw of funding"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Ganirelix used Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) — over how long?


studies of Ganirelix used the recorded amount. ClinicalTrials.gov · 2026-09-01

3 recorded entries; human; also "Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)", "the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix", "Ganirelix 0.25 mg."

Show the evidence

human

  • NCT00417066
    Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)
  • NCT01645241
    the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix
  • NCT02118051
    Ganirelix 0.25 mg.

recorded 2026-09-01 · last checked 2026-09-04

Which of an ongoing pregnancy, average blood cortisol concentration and average blood testosterone concentration did Ganirelix's trials measure?


an ongoing pregnancy, average blood cortisol concentration and average blood testosterone concentration lead 31 outcome terms across Ganirelix's trials. ClinicalTrials.gov · 2026-09-01

Interpretation development of ohss, pregnancy rates, endothelial function, an ongoing pregnancy, oocytes retrieved and mothers in current follow up trial experiencing serious aes follow.

Show the evidence
  • oocytes retrieved for ivf
    1
  • without premature luteinizing hormone surge
    1
  • ongoing pregnancy rate per embryo transfer
    1
  • development of ohss
    1
  • pregnancy rates
    1
  • endothelial function
    1
14 more recorded rows
  • an ongoing pregnancy
    1
  • oocytes retrieved
    1
  • mothers in current follow up trial experiencing serious aes
    1
  • infants born in current follow up trial experiencing aes
    1
  • infants in current follow up trial experiencing saes
    1
  • pregnancy rate
    1
  • ongoing pregnancy at week 8
    1
  • orthostatic tolerance
    1
  • baroreceptor function
    1
  • skin microvascular responses
    1
  • serious adverse events
    1
  • endometrial thickness measured by ultrasound
    1
  • cumulus oocyte complexes retrieved during oocyte pick up
    1
  • ongoing pregnancy
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Ganirelix's 5 ongoing trials reports first?


5 registered trials of Ganirelix are open; earliest completion 2025-12-31. ClinicalTrials.gov · 2026-09-01

Average Blood Cortisol Concentration; Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles; latest 2027-12-31

Show the evidence

Trial

  • NCT03142893
    "Hormonal Mechanisms of Sleep Restriction - Axis Study"; n 80; "Average Blood Cortisol Concentration"; 2026-06-30
  • NCT04037605
    "Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women"; n 5; "Average Blood Cortisol Concentration"; 2026-06-24
  • NCT06175832
    "PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study"; n 60; "Treatment-related quality of life and patient satisfaction after comparing two different ovulation stimulation cycles"; 2027-12-31
  • NCT06637189
    "Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A."; n 144; "Number of Euploid Embryos"; 2025-12-31
  • NCT06745466
    "Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women"; n 30; "Endothelium-dependent dilation (EDD)"; 2027-10

recorded 2026-09-01 · last checked 2026-09-04

Which 26 trials of Ganirelix posted no result?


Posted no result
26 of 26 completed trials
Registrations
NCT00702806, NCT00988260, NCT00298025, NCT00724789, NCT00417066 and NCT00461422, and 20 more
Completion dates
oldest 2002-10-15; newest 2024-01-29
Show the evidence

Trial

  • NCT00702806
    2002-10-15
  • NCT00988260
    2004-04-12
  • NCT00298025
    2004-05
  • NCT00724789
    2005-11
  • NCT00417066
    2006-07
  • NCT00461422
    2007-06
14 further recorded trials
  • NCT01304511
    2007-12
  • NCT00225433
    2008-06
  • NCT00823004
    2009-10
  • NCT00589134
    2009-12
  • NCT00734279
    2010-12
  • NCT00780858
    2011-03
  • NCT01286051
    2012-09
  • NCT00757185
    2012-12
  • NCT01645241
    2013-12
  • NCT01669291
    2014-05
  • NCT01816321
    2016-05
  • NCT02069808
    2017-03-08
  • NCT02118051
    2017-06
  • NCT02796105
    2017-07-10

At the median, Ganirelix's trials enrolled 145.5 people — anything larger?


Median enrolment
145.5
Largest enrolment
2066
Registered trials counted
52

What do 793 spontaneous reports say about Ganirelix — 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.

Ganirelix appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 793 reaction mentions were counted: ovarian hyperstimulation syndrome 401; ascites 154; dyspnoea 48; abdominal pain 38. open-targets-adr · CHEMBL1251 · 2026-06-24

Show the evidence
  • ovarian hyperstimulation syndrome
    401
  • ascites
    154
  • dyspnoea
    48
  • abdominal pain
    38
  • pleural effusion
    37
  • peritoneal haemorrhage
    26
4 more recorded rows
  • ovarian haemorrhage
    24
  • premature ovulation
    24
  • abortion spontaneous
    22
  • abdominal distension
    19

recorded 2026-06-24 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1251
PubChem CID
16130957
CAS number
124904-93-4
RxCUI
35825
InChIKey
GJNXBNATEDXMAK-PFLSVRRQSA-N
Trade name
Orgalutran, Ganirelix gedeon richter, Fyremadel
Also called
cetrorelix, cetrotide, GANIRELIX ACETATE, Ganirest, GANIRELIX ACETATE [JAN], GANIRELIX ACETATE [MART.], GANIRELIX ACETATE [MI], GANIRELIX ACETATE [ORANGE BOOK], GANIRELIX ACETATE [USAN], GANIRELIX ACETATE [VANDF], Ganirelix acetate [WHO-DD], N-ACETYL-3-(2-NAPHTHYL)-D-ALANYL-P-CHLORO-D-PHENYLALANYL-3-(3-PYRIDYL)-D-ALANYL-L-SERYL-L-TYROSYL-N(SUP 6)-(N,N'-DIETHYLAMIDINO)-D-LYSYL-L-LEUCYL-N(SUP 6)-(N,N'-DIETHYLAMIDINO)-L-LYSYL-L-PROLYL-D-ALANINAMIDE DIACETATE (SALT)
Salt form
Ganirelix acetate injection
Development code
RS-26306, RS-26306-298
Sources (7)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC and ClinicalTrials.gov organism ladder ·
  • open-targets-adr CHEMBL1251 ·
  • openfda-label 420ce739-2756-4fb4-8a4e-5fab501ab973 ·
1 more source

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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