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Somatrogon

  • Hormone
  • Still being tested
  • 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 Somatrogon does in the body

NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.

Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Somatrogon-ghla binding leads to activation of the STAT5b signaling pathway and increases the serum concentration of Insulin-like Growth Factor (IGF-1). GH and IGF-1 stimulate metabolic changes, linear growth, and enhance growth velocity in pediatric patients with GHD.

Why people take it. NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.

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 · 6D848RA61B · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 121 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 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.

Evaluate families and patients propensity with a questionnaire to envision a switch from rhGH treatment to LAGH

The study did not show it

Who was studied
NCT06542809
How many people
500
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.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Auxological evaluation_1

The study did not show it

Who was studied
NCT07173036
How many people
300
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.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Annual Height Velocity

The study did not show it

Who was studied
NCT07226089
How many people
254
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.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Annual Height Velocity in Main Study Phase

The study did not show it

Who was studied
NCT02968004
How many people
224
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.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire

The study did not show it

Who was studied
NCT03831880
How many people
87
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.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • Europe PMC · a recorded source, not a stored snapshot

Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)

The study did not show it

Who was studied
NCT03810664
How many people
49
Study design
Phase 1
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.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • Europe PMC · 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 No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
  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

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. 37.7 hours hours

    Read from the label, which states: “The mean population PK estimated effective half-life was 37.7 hours, which allows for weekly dosing.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

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

No description of who was studied is recorded.

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 NGENLA have been established for the treatment of growth failure due to inadequate secretion of endogenous growth hormone (GH) in pediatric patients aged 3 years and older [see Clinical Studies (14.1) ].”

    US prescribing information · 06dce529-b741-4a1b-8842-3ad77be6e308 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no available data on NGENLA use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”

    US prescribing information · 06dce529-b741-4a1b-8842-3ad77be6e308 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of somatrogon-ghla in human or animal milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · 06dce529-b741-4a1b-8842-3ad77be6e308 · 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

Still being tested

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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

  • 2 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.

    FDA National Drug Code directory · 0069-0520 · read 2026-08-29

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

    FDA National Drug Code directory · 0069-0520 · read 2026-08-29

  • The regulator's established pharmacologic class for it is 11-beta hydroxysteroid dehydrogenase type 1 inhibitors [moa], human growth hormone [cs] and recombinant human growth hormone [epc].

    FDA National Drug Code directory · 0069-0520 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 06dce529-b741-4a1b-8842-3ad77be6e308 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 06dce529-b741-4a1b-8842-3ad77be6e308 · read 2026-08-29

  • Ngenla is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS NGENLA (somatrogon-ghla) is a clear and colorless to slightly light yellow solution available as: • Injection: 24 mg/1.2 mL (20 mg/mL) in a single-patient-use, disposable prefilled pen that…, recorded as fda label in effect 2026-08-14 in the United States.

    US prescribing information · 06dce529-b741-4a1b-8842-3ad77be6e308 · 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, investigational agent. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Somatrogon 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 Somatrogon 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.

Where else this substance is registered

FDA substance identifier (UNII)
6D848RA61B
CAS registry number
1663481-09-1
WHO international nonproprietary name list entry
10402
EMA substance identifier
100000174673
DrugBank
DB14960

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: Quoted from a stored source.

  • 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

  • The earliest marketing start date recorded for a listed product is 20230731.

    FDA National Drug Code directory · 0069-0520 · 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

7 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.

  • What was measured, goal by goal — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — 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)

What did Somatrogon's largest trial (565 people) and its longest (7.4 years) measure?


565 people in Somatrogon's largest registered study, 7.4 years in its longest registered window, measuring Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt). ClinicalTrials.gov · 2026-09-01

4 phase3, 3 na or unstated, 1 phase1; NCT02968004; 2024-05; no ageing endpoint recorded. Last human test completed 2024, NCT02968004.

Interpretation These counts include studies where Somatrogon 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
  • phase3
    4
  • na or unstated
    3
  • phase1
    1
  • Last recorded human test NCT02968004
    2024-05

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

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


human: biomarker (8): the rungs where Somatrogon has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt) — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT03810664
    biomarker; Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt); 8

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

Human studies of Somatrogon used NGENLA 60mg SSOL 1x1.2mL PFP US — over how long?


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

1 recorded entry; human; also "NGENLA 60mg SSOL 1x1.2mL PFP US"

Show the evidence
  • human NCT07226089
    NGENLA 60mg SSOL 1x1.2mL PFP US

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

Somatrogon's half-life is 37.7 hours — which schedules were studied?


37.7 hours, the half-life Somatrogon's label states. openfda-label · 06dce529-b741-4a1b-8842-3ad77be6e308 · 2026-08-30

Show the evidence
  • half life
    37.7 hours hours; The mean population PK estimated effective half-life was 37.7 hours, which allows for weekly dosing.
  • metabolism
    12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism.

recorded 2026-08-30 · last checked 2026-09-04

Which of annual height velocity, annual height velocity after 12 months and annual height velocity in main study phase did Somatrogon's trials measure?


annual height velocity, annual height velocity after 12 months and annual height velocity in main study phase lead 7 outcome terms across Somatrogon's trials. ClinicalTrials.gov · 2026-09-01

Interpretation incidence of adverse events, reporting adverse events, reported adverse events and annual height velocity follow.

Show the evidence
  • annual height velocity in main study phase
    1
  • annual height velocity in ole phase
    1
  • annual height velocity after 12 months
    1
  • incidence of adverse events
    1
  • reporting adverse events
    1
  • reported adverse events
    1
1 more recorded row
  • annual height velocity
    1

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

Which of Somatrogon's 4 ongoing trials reports first?


4 registered trials of Somatrogon are open; earliest completion 2026-09-23. ClinicalTrials.gov · 2026-09-01

Incidence of adverse events (AEs); The number of patients reporting Adverse Events (AEs); latest 2029-04-06

Show the evidence

Trial

  • NCT05509894
    "Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone"; n 565; "Incidence of adverse events (AEs)"; 2026-09-23
  • NCT05602766
    "Ngenla Subcutaneous Injection Special Investigation"; n 1; "The number of patients reporting Adverse Events (AEs)"; 2029-04-06
  • NCT06587035
    "A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India."; n 50; "Number of adverse events in participants on Somatrogon"; 2028-09-05
  • NCT07226089
    "Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature."; n 254; "Annual Height Velocity"; 2028-01

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

Which one trial of Somatrogon posted no result?


Posted no result
1 of 1 completed trials
Registrations
NCT03810664
Completion dates
oldest 2019-04-19
Show the evidence
  • Trial NCT03810664
    2019-04-19

At the median, Somatrogon's trials enrolled 68.5 people — anything larger?


Median enrolment
68.5
Largest enrolment
565
Registered trials counted
8

Somatrogon and CYP450 and Cytochrome P450: shared by which compounds?


CYP450 and Cytochrome P450 appear in Somatrogon's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-14

Interpretation drug_interactions

Show the evidence
  • Cytochrome P450 drug_interactions
    Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance.

CYP450

  • drug_interactions
    NGENLA may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes.
  • drug_interactions
    Intervention: Careful monitoring is advisable when NGENLA is administered in combination with drugs metabolized by CYP450 liver enzymes.
  • Cytochrome P450 drug_interactions
    Intervention: Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents [see Warnings and Precautions (5.4) ] . • Replacement Glucocorticoid Treatment: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress dose following initiation of NGENLA ( 7 ). • Pharmacologic Glucocorticoid…

recorded 2026-08-14 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL4297830
CAS number
1663481-09-1
Also called
Ctp-somatropin fusion protein, Mod-4023, Somatrogon-ghla, Somatropin-ctp fusion protein, FUSION PROTEIN OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG- .BETA.)-(118-145)-PEPTIDE (1-28) WITH HUMAN SOMATOTROPIN (GROWTH HORMONE, GH) (29-219) AND TWO TANDEM COPIES OF HUMAN CHORIOGONADOTROPIN SUBUNIT .BETA. (CG-.BETA.)-(118-145)- PEPTIDE (220-247, 248-275), O-GLYCOSYLATED ON 12-18 SERINES, PRODUCED IN CHINESE HAMSTER OVARY (CHO) CELLS GROWTH HORMONE DERIVATIVE, HUMAN GROWTH HORMONE-CARBOXY-TERMINAL PEPTIDE (CTP) OF THE BETA CHAIN OF HUMAN CHORIONIC GONADOTROPIN FUSION PROTEIN, RECOMBINANT HUMAN GROWTH HORMONE LONG ACTING (FUSED W BETA CHAINS OF HCG), SOMATROGON [JAN], SOMATROGON [USAN]
Development code
MOD4023, PF-06836922, PF06836922
Trade name
Ngenla
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 ·
  • openfda-label 06dce529-b741-4a1b-8842-3ad77be6e308 ·
  • openfda-label+europepmc K1:6D848RA61B ·
1 more source

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · 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: 3 required field(s) not terminal: Best-supported result, 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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