This page shows what was measured, who it was measured in, and what that does not settle.
What Sermorelin does in the body
A childhood growth drug that was approved, then pulled — now compounded for anti-ageing
The hypothalamus makes a 44-amino-acid hormone that tells the pituitary to release growth hormone. The first 29 amino acids are the part that does the work, and sermorelin is exactly those 29 with a chemical cap on the end. Injected at bedtime it produces a pulse of growth hormone from the child own pituitary, which is why it only helps when the pituitary is intact and the problem is upstream. That is also the reason it never displaced growth hormone itself: giving the signal depends on a working factory, while giving the hormone does not. Its natural half-life is minutes, which is the limitation every later GHRH analogue in this file was designed to solve.
What happened in people
Height velocity rose from 4.1 to 8.0 cm/yr at six months and 7.2 cm/yr at twelve in 86 evaluable growth-hormone-deficient children on 30 ug/kg/day at bedtime, with 74% good responders
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That a first-year height velocity gain predicts a gain in final adult height, which was never determined for this drug
Where it acts
GHRH receptors on anterior pituitary somatotrophs
Kind of result
The kind of result is not recorded
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 · 89243S03TE · read 2026-08-29
Its recorded molecular formula is C149H246N44O42S, weighing 3357.9.
PubChem record · 16132413 · 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.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 167 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.
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.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
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.
Linear growth enhancement (height velocity), bone age progression and safety
✓ The study showed what it set out to show
Who was studied
Geref International Study Group, one-year multicentre open-label study
How many people
110
Study design
Multicentre open-label, up to 12 months
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Height velocity 4.1 +/- 0.9 cm/yr at baseline to 8.0 +/- 1.5 at 6 months and 7.2 +/- 1.3 at 12 months; 74% good responders at 6 months; bone age to height age ratio 1.04 +/- 0.58 (P = 0.63 versus unity)
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Open-label with no placebo arm, and 24 of 110 enrolled children were not eligible for the efficacy analysis. No adverse biochemical or hormonal changes, no change in fasting glucose, no excessive IGF-1 generation.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous injection, 30 micrograms per kilogram once daily at bedtime; single 1 ug/kg intravenous dose for the diagnostic use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Height velocity, height standard deviation score for bone age, and IGF-1, comparing GHRH(1-29) 30 and 60 ug/kg/day against growth hormone 0.1 IU/kg/day
✗ The study did not show it
Who was studied
Neyzi 1993 three-arm randomised comparison against growth hormone
How many people
43
Study design
Randomised three-arm, 6 months
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Height velocity lowest in the low-dose GHRH arm and comparable between high-dose GHRH and growth hormone; an increase in height SDS for bone age occurred only in the growth hormone group
Repeated elsewhere
Partially Replicated
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. Subcutaneous injection, 30 micrograms per kilogram once daily at bedtime; single 1 ug/kg intravenous dose for the diagnostic use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Growth response to GHRH in deficiency of hypothalamic origin
✓ The study showed what it set out to show
Who was studied
Ogilvy-Stuart 1997 study in radiation-induced growth hormone deficiency
How many people
0
Study design
Open-label treatment study in children after cranial irradiation
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Growth hormone-releasing hormone produced a growth response in radiation-induced deficiency, the setting where the lesion is above the pituitary and the pituitary remains responsive
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
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. Subcutaneous injection, 30 micrograms per kilogram once daily at bedtime; single 1 ug/kg intravenous dose for the diagnostic use
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 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 it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Sermorelin
What a person takes: Subcutaneous injection, 30 micrograms per kilogram once daily at bedtime; single 1 ug/kg intravenous dose for the diagnostic use.
The measurement behind this step
Supplied as sermorelin acetate for reconstitution. The therapeutic regimen was a bedtime subcutaneous injection timed to the nocturnal growth hormone surge; the diagnostic use was a single intravenous dose with timed growth hormone sampling. Present-day compounded vials follow no approved specification, and the asparagine at position 8 and methionine at position 27 make storage-related deamidation and oxidation a real quality question rather than a theoretical one.
Getting in
Injected under the skin, usually at bedtime
A once-daily injection timed for night, because that is when the body normally releases most of its growth hormone.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The approved paediatric regimen was 30 micrograms per kilogram per day subcutaneously at bedtime, chosen to align an exogenous GHRH pulse with the endogenous nocturnal surge. The diagnostic use was a single 1 microgram per kilogram intravenous dose.
An enzyme in blood clips this peptide apart within minutes, so the dose has to be large enough to get there first.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Dipeptidyl peptidase IV cleaves the Ala2-Asp3 bond, giving a plasma half-life of minutes. The anterior pituitary sits outside the blood-brain barrier and is reached directly from the circulation. This single vulnerability is why every subsequent GHRH analogue substitutes position 2.
It fits the same receptor the natural brain hormone uses, because it is the working part of that hormone.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Full agonist at the GHRH receptor, a class B G protein-coupled receptor coupled to Gs, adenylyl cyclase and cyclic AMP. The 15 C-terminal residues of native GHRH(1-44) contribute nothing to receptor activation, which is why the 1-29 fragment is the drug.
The hormone comes from the child own gland, so the normal feedback controls still apply and it cannot be pushed arbitrarily high.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Cyclic AMP-driven exocytosis of stored growth hormone from somatotroph granules, with the response constrained by somatostatin tone and by pituitary reserve. In the one-year paediatric study this produced no excessive IGF-1 generation and no change in fasting glucose — the ceiling imposed by physiological feedback is the mechanistic reason for that.
Real growth, less growth than the hormone itself, no adult-height answer
Children grew faster. They grew faster still on growth hormone. Nobody measured what either did to final height in this programme.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Height velocity 4.1 to 8.0 cm/yr at six months and 7.2 cm/yr at twelve, with 74% good responders and bone age advancing in step with height age. Head-to-head at the same microgram-per-kilogram dose, somatropin produced larger height velocity increases, and only the somatropin arm improved height standard deviation score for bone age. Final adult height was never determined for sermorelin.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
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.
On label, when it was available: children with idiopathic growth hormone deficiency, and patients undergoing a provocative pituitary test. Now: adults receiving compounded sermorelin from wellness clinics for indications that were never studied, and people buying it as a research chemical.
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.
Where the result stopped carrying
Sermorelin never demonstrated an effect on final adult height, the outcome the indication exists for
Both approved products were discontinued, ending the only regulated supply of a GHRH analogue for growth failure
The head-to-head comparisons that exist favour growth hormone replacement over GHRH stimulation
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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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
Withdrawn
❝ 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
Subcutaneous injection, 30 micrograms per kilogram once daily at bedtime; single 1 ug/kg intravenous dose for the diagnostic use
✎ 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: S11, S1.
No source is stored against this line.
What is in the pack
Supplied as sermorelin acetate for reconstitution. The therapeutic regimen was a bedtime subcutaneous injection timed to the nocturnal growth hormone surge; the diagnostic use was a single intravenous dose with timed growth hormone sampling.
✎ 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. The rest of the recorded wording: Present-day compounded vials follow no approved specification, and the asparagine at position 8 and methionine at position 27 make storage-related deamidation and oxidation a real quality question rather than a theoretical one.
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◇Read from sources, not yet reviewed
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.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
In the one-year paediatric study, no adverse changes in general biochemical or hormonal analyses, no change in fasting glucose and no excessive IGF-1 generation. The commonest reported adverse events across single intravenous and repeated subcutaneous dosing were transient facial flushing and injection-site pain. Because the growth hormone released is the patient own and remains under somatostatin feedback, the acromegalic risks of supraphysiological exogenous growth hormone do not apply in the same way. There is no safety dataset for adult use over months or years, because no such trial was run.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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
Subcutaneous injection, 30 micrograms per kilogram once daily at bedtime; single 1 ug/kg intravenous dose for the diagnostic use
✎ 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
The therapeutic regimen was a bedtime subcutaneous injection timed to the nocturnal growth hormone surge; the diagnostic use was a single intravenous dose with timed growth hormone sampling.
✎ 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 which forms are sold. The rest of the recorded wording: Present-day compounded vials follow no approved specification, and the asparagine at position 8 and methionine at position 27 make storage-related deamidation and oxidation a real quality question rather than a theoretical one.
No source is stored against this line.
What is recorded as being sold
18 products list this as an active ingredient in the United States drug directory. 18 of them contain it and nothing else.
FDA National Drug Code directory · 83589-102 · read 2026-08-29
They are sold as powder.
FDA National Drug Code directory · 83589-102 · read 2026-08-29
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, withdrawn medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Sermorelin 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
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That a first-year height velocity gain predicts a gain in final adult height, which was never determined for this drug
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a historical approval in children supports adult use for ageing, body composition, sleep or recovery — indications with no controlled trial of sermorelin
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a normal growth hormone response to sermorelin excludes growth hormone deficiency, which it specifically does not when the lesion is hypothalamic
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That results from tesamorelin, an approved and differently substituted GHRH analogue, transfer to sermorelin
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
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 Sermorelin 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.
Every line above can be traced to the study named beside it. Follow the link and read it.
Height velocity nearly doubled in growth-hormone-deficient children
In plain words
In 110 previously untreated children with growth hormone deficiency, a bedtime injection raised growth from 4.1 cm a year to 8.0 cm a year at six months, with 74% classed as good responders.
What was measured
Height velocity in cm per year at baseline, 6 months and 12 months, with bone age to height age ratio
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Thorner et al., for the Geref International Study Group, treated 110 previously untreated prepubertal growth-hormone-deficient children in a multicentre open-label study with 30 micrograms per kilogram per day of GHRH(1-29) subcutaneously at bedtime for up to one year; 86 were eligible for efficacy analysis. Mean height velocity rose from 4.1 +/- 0.9 cm/yr at baseline to 8.0 +/- 1.5 cm/yr at six months and 7.2 +/- 1.3 cm/yr at twelve. At six months, 74% were considered good responders. The ratio of change in bone age to change in height age was not significantly different from unity at twelve months (1.04 +/- 0.58, P = 0.63), meaning skeletal maturation did not run ahead of growth. No adverse changes in biochemical or hormonal analyses were seen, no change in fasting glucose, and no excessive IGF-1 generation.
Written into the record, not signed off as a reviewed claim
It worked, and growth hormone worked better at the same dose
In plain words
Giving the releasing signal raised growth less than giving growth hormone itself, and only the growth hormone arm improved height relative to bone age.
What was measured
That stimulating endogenous growth hormone is equivalent to replacing it — the comparisons that exist favour replacement
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The published review of sermorelin states directly that increases in height velocity with subcutaneous sermorelin 30 micrograms per kilogram per day, given by continuous infusion or in three divided doses, were less than those in children receiving once-daily subcutaneous somatropin at the same 30 micrograms per kilogram, and that the effects at the recommended dose were never compared head to head with somatropin. Neyzi et al. randomised 43 prepubertal children with growth hormone deficiency of hypothalamic origin to low-dose GHRH(1-29) at 30 micrograms per kilogram per day, high-dose at 60, or growth hormone at 0.1 IU per kilogram per day for six months. Height velocity was lowest in the low-dose arm and comparable between high-dose GHRH and growth hormone, but an increase in height standard deviation score for bone age occurred only in the growth hormone group. The releasing-hormone route works and, on the measurements that were taken, it works less well.
Written into the record, not signed off as a reviewed claim
The effect on adult height was never determined
In plain words
Sermorelin was approved to treat growth failure in children and no study ever established what it did to final adult height.
What was measured
Trials reporting final adult height after sermorelin treatment: none
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The efficacy record consists of one-year height velocity data in 86 evaluable children, with sustained effect reported in a small number followed to 36 months. The published review states plainly that the effect of long-term once-daily subcutaneous sermorelin at 30 micrograms per kilogram on final adult height is yet to be determined. Height velocity in the first year of treatment is a surrogate: it is a real measurement and it is not the outcome the treatment exists to change. Both Geref products are now listed as discontinued in Drugs@FDA, so the question will not be answered by the approved product.
Source
Prakash A, Goa KL, BioDrugs 1999;12:139-157; Drugs@FDA records NDA 019863 and NDA 020443, both marketing status Discontinued
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
As a diagnostic test, a normal result does not rule the disease out
In plain words
Sermorelin was approved as a pituitary test, and the label limitation is that a normal growth hormone response does not exclude deficiency caused by a problem in the hypothalamus.
What was measured
Growth hormone response to a single intravenous 1 ug/kg dose, and its interpretation limits in hypothalamic deficiency
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The approved diagnostic use is a single intravenous 1 microgram per kilogram dose with growth hormone sampled afterwards, used alongside conventional provocative tests. The recognised limitation is structural rather than technical: sermorelin bypasses the hypothalamus and tests the pituitary directly, so a hypothalamic cause of deficiency produces a normal response. A subnormal response to other provocative tests is required to confirm disease in those patients. Adding arginine to intravenous sermorelin was reported to make the test more specific. This is an unusually honest piece of diagnostic labelling and it is worth reading next to the marketing of GHRH peptides as general pituitary stimulants.
Written into the record, not signed off as a reviewed claim
Approved, marketed, discontinued — and then reborn as a wellness product
In plain words
Both approved sermorelin products were taken off the market. It is now sold by compounding pharmacies for adult anti-ageing, an indication no regulator ever reviewed.
What was measured
That a historical FDA approval for childhood growth failure supports adult use for ageing, body composition or recovery
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Drugs@FDA lists NDA 019863 (approved 28 December 1990, with supplements through 2001) and NDA 020443 (approved 26 September 1997), both sponsored by EMD Serono, both with all products in marketing status Discontinued. The approved indications were diagnostic pituitary testing and treatment of idiopathic growth hormone deficiency in children with growth failure. Neither approval covered adults, body composition, sleep quality, recovery, or ageing. The current supply is compounded, and the indications it is compounded for have no approved-product evidence base at all. A product that once had an FDA label and now does not is not a product with a stronger evidence base than the unapproved peptides beside it; it is the same evidence base, minus the marketing authorisation.
Source
Drugs@FDA application records NDA 019863 and NDA 020443 (EMD Serono), marketing status Discontinued for all listed products
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The adult use has no controlled trial at all
In plain words
The reason adults are prescribed sermorelin today — better sleep, more lean mass, feeling younger — has never been tested against placebo in a trial of this drug.
What was measured
That sermorelin improves body composition, sleep or wellbeing in adults, an indication with no controlled trial of this compound
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The registered and published human efficacy literature for sermorelin is in children with growth hormone deficiency or idiopathic short stature, plus provocative pituitary testing and radiation-induced growth hormone deficiency. There is no placebo-controlled trial of sermorelin in healthy or ageing adults for body composition, sleep architecture, exercise capacity or quality of life. GHRH analogues have been studied in adults in other contexts — tesamorelin is approved for HIV-associated lipodystrophy — but tesamorelin is a different molecule with a different label, and its results are not sermorelin results.
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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.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — 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.
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.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
The only compound in this group that was approved, marketed and then discontinued: it raised height velocity in growth-hormone-deficient children from 4.1 to 8.0 cm per year at six months, raised it less than growth hormone did at the same dose, never established an effect on final adult height, and now exists only as a compounded product for uses no regulator has looked at.
Recorded evidence blocks (1)
Q3
Where do the label and the trials disagree about Sermorelin?
"withdrawn" against "approved": withdrawal status vs register status for Sermorelin.
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 3 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
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.