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MonographSermorelin

Sermorelin: GRF(1-29) identity, evidence and a licence that ended

The amidated 1-29 fragment of human GHRH, once approved in the United States as Geref and discontinued in 2008. Identifiers for the free base and the acetate, the small clinical literature, and dated status in four jurisdictions.

Last reviewed
2026-09-22
Reviewer
editorial review pending
Revision
1
Sources
39

Summary

Sermorelin is the C-terminally amidated 1-29 fragment of human growth hormone-releasing hormone (GHRH, also called growth hormone-releasing factor, GRF): a 29-residue synthetic peptide and an agonist at the GHRH receptor 12. Its sequence is identical to residues 1-29 of mature human somatoliberin, and C-terminal amidation is its only modification 34.

Unlike most compounds in this pillar, sermorelin has a completed licensed history. Sermorelin acetate was the active ingredient of two fully approved United States medicines marketed as Geref, and both were discontinued and their approvals withdrawn at the holder's request effective 18 June 2009; FDA determined in 2013 that the withdrawal was not for reasons of safety or effectiveness 5678. No marketing authorisation in force was found in the United Kingdom, the European Union or the United States on 21 September 2026, and DailyMed holds no current label 91011. The compound is named in section S2.2.4 of the WADA Prohibited List and is prohibited at all times 12.

Identity · Sermorelinverified 2026-09-21
Synonyms
GRF(1-29)NH2, GHRH(1-29)NH2, hGHRH(1-29)NH2, Growth hormone-releasing factor (human)-(1-29)-peptide amide, Somatotropin-releasing-hormone(1-29)amide, Groliberin, Sermorelinum, Sermoreline, Sermorelina, Sermorelin acetate (USAN), Geref (brand)
CAS
86168-78-7· PubChem, NCBI/NLM, FDA / NCATS GSRS
UNII
89243S03TE· PubChem, NCBI/NLM, FDA / NCATS GSRS
PubChem CID
16132413
Formula
C149H246N44O42S· PubChem, NCBI/NLM
Mol. weight
3357.9 g/mol· PubChem, NCBI/NLM, FDA / NCATS GSRS, Qualitative identification of growth hormone-releasing hormones in human plasma by means of immunoaffinity purification and LC-HRMS/MS
Class
Synthetic linear 29-residue peptide amide; N-terminal 1-29 fragment of human growth hormone-releasing hormone (GHRH, somatoliberin); GHRH receptor agonist. ATC H01AC04 and V04CD03.
Targets
Growth hormone-releasing hormone receptor (GHRHR; ChEMBL target CHEMBL2032), agonist
Modifications
C-terminal amidation: residue 29 is L-argininamide (GSRS records an amino-acid substitution ARGININE -> ARGININAMIDE, L- at position 29). Free N-terminus (H-Tyr1). Sequence is identical to residues 1-29 of mature human somatoliberin (UniProt P01286 residues 32-60); no non-natural residues. No disulfide bonds (no Cys).
Sequence (one-letter) · 29 residues
  1. Y
  2. A
  3. D
  4. A
  5. I
  6. F
  7. T
  8. N
  9. S
  10. Y
  11. R
  12. K
  13. V
  14. L
  15. G
  16. Q
  17. L
  18. S
  19. A
  20. R
  21. K
  22. L
  23. L
  24. Q
  25. D
  26. I
  27. M
  28. S
  29. R

Identity and structure

The free base and the acetate

The drug substance of the marketed product was an acetate salt, and the two forms have separate registry records. The free base carries CAS 86168-78-7, UNII 89243S03TE and PubChem CID 16132413, with the formula C149H246N44O42S and an average mass of 3357.9 g/mol; GSRS gives a sequence-calculated 3357.91 Da, and the monoisotopic mass reported by doping-control work is 3355.8 Da 13414. The acetate carries UNII 00IBG87IQW and USAN code AA-87, and GSRS describes it as the peptide with acetic acid and water moieties 15. Geref strengths were expressed as milligrams of base 6. Other identifiers recorded for the free base are INN number 6036, ATC codes H01AC04 and V04CD03, DrugBank DB00010, ChEBI 9118 and IUPHAR 6998 4.

Three conflicts in the public record bear on any certificate of analysis. The acetate CAS number differs between sources: GSRS gives 114466-38-5 as primary, while PubChem CID 16132412 lists 516482-86-3 as its first CAS-format synonym and carries 114466-38-5 only inside a free-text depositor string 1516. The free-base formula differs too: PubChem gives C149H246N44O42S, GSRS an "estimated" C149H247N44O43S, one hydrogen and one oxygen more, which would be consistent with a sequence-derived estimate that ignores the C-terminal amide, although GSRS does not say so 134. And the cross-references disagree: the PubChem record bearing UNII 00IBG87IQW is CID 16132412, drawn as a 1:1 acetate at 3417.9 g/mol, whereas GSRS links the acetate to CID 91820622, the acetate hydrate at 3436.0 g/mol 161715. The true acetate and water content of the drug substance is not stated by any retrieved source.

Sequence and modifications

The one-letter sequence is YADAIFTNSYRKVLGQLSARKLLQDIMSR with an amidated C-terminus, 29 residues 4214. GSRS records residue 29 as L-argininamide in place of arginine; the N-terminus is free, there are no cysteines and no disulfide bonds, and no non-natural residues are present 413. The sequence corresponds to positions 32 to 60 of UniProt P01286, within the mature 44-residue somatoliberin that spans positions 32 to 75 and itself ends in leucine amide 3. Prakash and Goa describe sermorelin as the shortest synthetic peptide with the full biological activity of GHRH, and Grossman and colleagues found GHRH(1-29)NH2 equipotent to GHRH(1-40) in normal subjects 118.

Three positions in this scaffold are chemical liabilities, and all three were exploited in the later analogues of the family: the Tyr1-Ala2 to Asp3 bond, which dipeptidyl peptidase IV cleaves; Asp3 and Asn8, which isomerise and deamidate respectively; and Met27, which oxidises in air, with norleucine substitution at position 27 conferring stability in analogues 19202122.

Mechanism and pharmacology

The target is the GHRH receptor: ChEMBL records the mechanism as growth hormone-releasing hormone receptor agonist against target CHEMBL2032 2. The cloned human receptor is a seven-transmembrane G protein-coupled receptor of the secretin and VIP receptor family, expressed predominantly in the anterior pituitary, and GHRH binding stimulates intracellular cAMP production in transfected cells 23. Intravenous and subcutaneous sermorelin specifically stimulate growth hormone secretion from the anterior pituitary 1. In normal subjects, raising the administered amount lengthened growth hormone release more than it raised the peak concentration 18.

Metabolism in plasma is dominated by dipeptidyl peptidase IV, which cleaves GRF peptides including GRF(1-29)-NH2 at the 2-3 bond to give the (3-29) fragment; trypsin-like cleavage at the 11-12 bond, and at 12-13 for the shortened fragments, is a lesser route 19. Purified human placental DPP-IV cleaved GRF(1-44)-NH2 and GRF(1-29)-NH2 at similar initial rates 20. The (3-29) metabolite was detected by LC-HRMS/MS in human plasma 30 minutes after a single subcutaneous administration and was no longer detectable at 90 minutes 14. In anaesthetised rats, immunoreactive hGRF(1-29)NH2 disappeared biphasically with half-lives of 1.9 ± 0.2 minutes for distribution and 10.4 ± 0.2 minutes for elimination, and subcutaneous exposure was about 4% of intravenous 24. No human pharmacokinetic values were retrieved for the dossier.

In the paediatric data reviewed by Prakash and Goa, transient facial flushing and injection-site pain were the most commonly reported adverse events 1. A 2006 editorial argued for use of sermorelin in adult-onset growth hormone insufficiency and stated that the product could not compete with recombinant human growth hormone and had been withdrawn by its manufacturer; that is opinion rather than trial evidence, and it predates the 2008 notification letters recorded by FDA 258.

Clinical and preclinical evidence

The human literature is small and mostly predates trial registration. It consists of one multicentre paediatric efficacy study from the licensed era, two early clinical pharmacology studies, one open uncontrolled study in older men comparing each participant with his own baseline, and one preclinical kinetic study in rats. Evidence level is stated in the design column.

Studies as reported · design and results from the cited publication or registry record
StudyDesignnInterventionComparatorDurationPrimary endpointResult
Geref International Study Group (Thorner et al. 1996)none (pre-registry)Multicentre, open-label, uncontrolled paediatric efficacy study in previously untreated prepubertal growth hormone-deficient children; 86 of 110 eligible for the efficacy analysis110GHRH-(1-29) 30 micrograms/kg/day subcutaneously at bedtime (study design)baseline height velocityup to 12 monthsHeight velocity; bone-age progression; safetyMean height velocity rose from 4.1 ± 0.9 cm/yr at baseline to 8.0 ± 1.5 at 6 months and 7.2 ± 1.3 cm/yr at 12 months; 74% classed as good responders at 6 months; bone-age to height-age change ratio 1.04 ± 0.58 (P = 0.63 against unity); no adverse biochemical changes reported. [thorner-1996-jcem]
Grossman et al. 1984 (analogue comparison)noneEarly clinical pharmacology: acute comparison of GHRH(1-40), GHRH(1-29)NH2 and D-Ala2-GHRH(1-29)NH2 in normal subjects and in growth hormone-deficient children and young adults20GHRH analogues, 10 to 200 micrograms per subject in the dose-ranging part (study design)GHRH(1-40)acute testsSerum growth hormone responseGHRH(1-29)NH2 was equipotent to GHRH(1-40); increasing the amount given prolonged growth hormone release with poor correlation to the peak; the D-Ala2 analogue was no more potent; 8 of 20 growth hormone-deficient participants showed normal or slightly subnormal responses. The n column is the deficient group; the normal-subject number is not in the abstract. [grossman-1984-clinendocrinol]
Corpas et al. 1992 (older men)noneRandomised-order two-dose within-subject study with a 14-day untreated interval, in healthy non-obese men; young men as an untreated reference group19GHRH-(1-29) 0.5 mg and 1 mg subcutaneously twice daily, each for 14 days, in the older men (study design)own baseline; untreated young men14 days per level24-hour growth hormone secretion profile and serum IGF-IDose-related increases; at the higher level, mean 24-hour growth hormone (P below 0.001), area under peaks (P below 0.001), peak amplitude (P below 0.05) and IGF-I (P below 0.005) rose against baseline, removing the difference from young men; no effect on fasting glucose, blood pressure or routine chemistry. [corpas-1992-jcem]
Vittone et al. 1997 (healthy elderly men)noneOpen, uncontrolled before-after study in healthy ambulatory non-obese men aged 64 to 76 with low baseline IGF-I11GHRH(1-29) 2 mg subcutaneously nightly (study design)own baseline6 weeksNocturnal growth hormone secretion, IGF-I, muscle strength, 31P-NMR muscle bioenergetics, body compositionMean nocturnal growth hormone release (P below 0.02), area under the growth hormone peak (P below 0.006) and peak amplitude (P below 0.05) increased; IGF-I, IGFBP-3 and GHBP unchanged; 2 of 6 strength measures improved; no change in weight or DEXA body composition; no significant adverse effects. [vittone-1997-metabolism]
Rafferty et al. 1985 (rat kinetics)nonePreclinical: radioimmunoassay pharmacokinetic study in anaesthetised rats, intravenous against subcutaneousnot given in the abstracthGRF(1-29)NH2 10 micrograms intravenously, with a subcutaneous comparison (study design)route comparisonacuteImmunoreactive peptide disappearance half-lives; relative subcutaneous exposureBiphasic disappearance with half-lives of 1.9 ± 0.2 minutes and 10.4 ± 0.2 minutes; subcutaneous exposure about 4% of intravenous. [rafferty-1985-jendocrinol]

Review-level context comes from Prakash and Goa, who summarise the diagnostic use as a single intravenous test with fewer false-positive responses than other provocative tests, while noting that a normal response cannot exclude hypothalamic growth hormone deficiency; and the treatment data as height-velocity gains sustained for 12 months, with data in a few children to 36 months, an undetermined effect on final height, no direct comparison of the recommended regimen with somatropin, and smaller height-velocity gains than somatropin in the comparisons that do exist 1. An intervention search of ClinicalTrials.gov for sermorelin on 21 September 2026 returned 27 records, most of them tesamorelin or generic GHRH studies matched by synonym, and none was used as a source here.

Evidence level

Licensed-era paediatric efficacy data from one multicentre open-label study (n = 110), two early clinical pharmacology studies, one open before-after study in older men (n = 11) and rat pharmacokinetics. No placebo-controlled trial of the compound is recorded in the dossier, and no registered trial supplied results 26182724.

Analytical characterisation

No pharmacopoeial monograph was retrieved or checked, because the USP-NF and the European Pharmacopoeia are not openly fetchable 1.

The published method with full parameters is a doping-control one. Immunoaffinity purification with a polyclonal GHRH antibody on protein A/G monolithic tips is followed by nano-UHPLC on a C18 trapping column and a C18 analytical column with 0.1% formic acid and acetonitrile containing 0.1% formic acid, with detection on a Q Exactive instrument in positive electrospray. Sermorelin has a monoisotopic mass of 3355.8 Da and gives the 5+ charge state at m/z 672; the GHRH(3-29) metabolite has a monoisotopic mass of 3121.8 Da at m/z 625. Reported validation figures are recovery of 19 to 37%, a limit of detection below 50 pg/mL and imprecision below 20% 14. HPLC was the tool used to follow the kinetics of DPP-IV proteolysis of GRF(1-29)-NH2 and to isolate and characterise its degradation products 2021.

The degradation literature also predicts the product-related impurities to look for: the beta-Asp8 and Asp8 forms arising from Asn8 deamidation, in a ratio of about 4 to 1; the beta-Asp3 form from Asp3 isomerisation; and GRF(4-29)-NH2 from Asp3-Ala4 cleavage in acid 21. Met27 oxidation is a recognised liability of the same scaffold 22. All characterised degradation products had much lower in vitro potency than the parent peptide, and for a related analogue the beta-Asp8 form was 400 to 500-fold and the alpha-Asp8 form about 25-fold less potent 2128.

Analytical data

Certificates of analysis, identity data and lot verification for the research material characterised on this page.

View analytical data · CJC-1295 / Ipamorelin / Sermorelin blend →

Stability and handling

Laboratory handling data from the literature only. The labelled storage conditions of the discontinued product could not be verified from an allowed source: DailyMed holds no label for sermorelin, the Drugs@FDA review documents are image scans, and the solubility and both storage fields are recorded as null in the dossier 116.

In aqueous solution, GRF is reported to be most stable at pH 4 to 5. Below pH 4, cleavage at the Asp3-Ala4 bond dominates; above pH 4, Asp3 isomerises to beta-Asp3; Asn8 deamidation, proceeding through a cyclic imide and general base-catalysed, occurs from pH 5 upward and is the faster of the two processes; direct hydrolysis of Asn8 to Asp8 was seen at pH 2 and below. Deamidation of Asn8 in GRF(1-29)-NH2 at pH 8.0 was relatively insensitive to temperature below 37 °C 21. For the related analogue [Leu27]hGRF(1-32)NH2 the disappearance half-life at pH 7.4 and 37 °C was 202 hours, driven by Asn8 deamidation, while serine-8 analogues were markedly more stable at 746 to 1550 hours; those figures are for the analogue, not for sermorelin 28. In biological medium the picture is different again: sermorelin was entirely degraded after four hours of incubation in human plasma at 37 °C, with DPP-IV as the principal enzyme 1419.

Regulatory status

The dated per-jurisdiction rows below are rendered from the database and cover the United Kingdom, the European Union, the United States and the WADA Prohibited List 8912.

Regulatory status · SermorelinInvestigational or unlicensed compound

No medicine containing this compound is authorised in any jurisdiction checked. It has no established safety profile in humans outside registered clinical research. It is supplied for laboratory research only.

The rows below record the absence of authorisation and any compounding, evaluation or anti-doping status found on the date checked.

United Kingdom
No sermorelin product was found in the MHRA products register or the eMC on 2026-09-21; sermorelin was added to the UK prescription-only substances schedule by SI 1993/1890.Checked 2026-09-21 · Medicines and Healthcare products Regulatory Agency
European Union
No centrally authorised, withdrawn or refused medicine containing sermorelin appears in the EMA medicines dataset generated on 2026-09-21; national authorisations were not verified.Checked 2026-09-21 · European Medicines Agency
United States
Formerly FDA-approved as Geref (sermorelin acetate; EMD Serono) under NDA 019863 (1990) and NDA 020443 (1997); both are listed as Discontinued, and FDA determined in 2013 that they were not withdrawn for reasons of safety or effectiveness.Checked 2026-09-21 · US Food and Drug Administration
WADA Prohibited List
Sermorelin is named in section S2.2.4 (growth hormone releasing factors) of the Prohibited List shown as the latest version on wada-ama.org on 2026-09-21 (2026 List); S2 is prohibited at all times.Checked 2026-09-21 · World Anti-Doping Agency

Regulatory timeline: a licensed history that ended

Sermorelin has a licensed history, and it ended. Sermorelin acetate was approved in the United States as Geref: NDA 019863, 0.05 mg base per ampoule, EMD Serono, approved on 28 December 1990 as a Type 1 new molecular entity and indicated for evaluating the ability of the pituitary somatotroph to secrete growth hormone; and NDA 020443, 0.5 mg and 1 mg base per vial, EMD Serono Inc, approved on 26 September 1997 as a Type 3 new dosage form with orphan designation and indicated for idiopathic growth hormone deficiency in children with growth failure 568. EMD Serono notified FDA of discontinuation by letters of 11 July 2008 for NDA 19-863 and 2 December 2008 for NDA 20-443, and requested withdrawal of NDA 19-863 on 12 December 2008; FDA withdrew approval of both applications at the holder's request, because the products were no longer marketed, effective 18 June 2009 87. Following a citizen petition of 12 October 2012, FDA determined under 21 CFR 314.161 that both Geref products were not withdrawn from sale for reasons of safety or effectiveness, kept them in the Orange Book discontinued drug product list, and stated that abbreviated applications referring to them may be approved 8. The discontinuation was therefore commercial, not a safety action.

No current authorisation was found anywhere. DailyMed returned no label for sermorelin; the MHRA products register and the electronic medicines compendium each returned no result, and the GOV.UK search interface returned none; and the EMA medicines dataset generated on 21 September 2026, which does contain tesamorelin, has no entry for sermorelin, Geref or somatorelin 119293010. The United Kingdom does have a legislative trace: SI 1993/1890, made on 23 July 1993 and in force from 23 August 1993, inserted "Sermorelin" into Part I of Schedule 1 to the 1983 Prescription Only Order, which shows prescription-only control of the substance in 1993 without establishing that any product licence existed 31. National authorisations in EU member states, past or present, were not verified from any allowed source 10.

Because no licence is in force in any tracked jurisdiction, the compound's archetype is recorded as investigational, and the licensed history above is stated in this timeline rather than implied by the archetype. The researcher's own recommendation in the dossier was the licensed-medicine archetype with a mandatory licence-ended qualifier; the lead engineer recorded the investigational value on 22 September 2026 on the ground that the licensed-medicine template asserts a current licence somewhere and none exists 8910.

On compounding, sermorelin does not appear in 21 CFR 216.23 or 21 CFR 216.24, in any of FDA's 503A Category 1, 2 or 3 lists in the document updated 14 May 2026, or on FDA's page of bulk substances that may present significant safety risks, which does name ipamorelin acetate, CJC-1295, GHRP-2, GHRP-6 and ibutamoren 32333435. FDA states that a bulk substance may be used under section 503A if it complies with a USP or NF monograph or, absent a monograph, is a component of an FDA-approved drug product, and its interim-policy guidance points to the Orange Book for determining component status; no retrieved FDA document states expressly how that applies to sermorelin acetate now that both approvals have been withdrawn 3637. An FDA advisory-committee briefing document of 29 October 2024 refers to compounding of ipamorelin and sermorelin combination products and describes sermorelin (Geref, NDA 020443) as the only growth hormone secretagogue that was approved for paediatric short stature associated with growth hormone deficiency 38.

Open questions

  1. The acetate CAS number is unresolved: GSRS gives 114466-38-5 and PubChem lists 516482-86-3 first; one may denote a hydrate or a separate registration 1516.
  2. The free-base formula differs between PubChem and the GSRS estimate by one hydrogen and one oxygen, and the acetate and water stoichiometry of the drug substance is unverified 134.
  3. The Geref prescribing information could not be retrieved from an allowed source, so composition, excipients, storage, solubility and labelled human pharmacokinetics all remain null 111.
  4. Whether a United Kingdom product licence was ever granted, with holder, number and dates, and whether sermorelin remains named in current prescription-only provisions, were not verified 319.
  5. Any national authorisations in EU member states are unverified; only the absence of a centralised record was established 10.
  6. Whether a USP or NF monograph exists, and how FDA's component-of-an-approved-product route applies to sermorelin acetate after the withdrawals, are not stated in any retrieved FDA document 3637.
  7. The 2026 WADA list PDF could not be opened by automated retrieval and the HTML list was read instead; a reviewer should confirm the S2.2.4 wording against the PDF 12.
  8. The date on which marketing actually ceased is uncertain: a 2006 editorial already described the product as withdrawn by its manufacturer, earlier than the 2008 notification letters recorded by FDA 258.

Questions this page answers

Is sermorelin an approved medicine?
Not now. It was approved in the United States as Geref (sermorelin acetate, EMD Serono) under NDA 019863 in 1990 for diagnostic use and NDA 020443 in 1997 for idiopathic growth hormone deficiency in children. Both are listed as discontinued and their approvals were withdrawn at the holder's request effective 18 June 2009. No marketing authorisation in force was found in the United Kingdom, the European Union or the United States on 21 September 2026.
Was Geref withdrawn because of a safety problem?
No. Following a citizen petition, FDA determined in 78 FR 14095 of 4 March 2013 that both Geref products were not withdrawn from sale for reasons of safety or effectiveness, kept them in the Orange Book discontinued drug product list, and stated that abbreviated applications referring to them may be approved. The withdrawal was requested by the holder because the products were no longer marketed.
What is the difference between sermorelin and CJC-1295?
Sermorelin is the unsubstituted amidated 1-29 fragment of human GHRH, identical in sequence to residues 1-29 of mature somatoliberin. CJC-1295 is a tetrasubstituted version of the same fragment, in its DAC form extended by a thirtieth lysine residue bearing a maleimidopropionamide group that binds covalently to serum albumin. The substitutions and the albumin conjugate are what distinguish the two.
Why does sermorelin carry the investigational archetype?
Because the site's licensed-medicine archetype asserts a marketing authorisation in force somewhere, and none exists. The licensed history is recorded in full in the regulatory timeline rather than in the archetype field. The researcher's own recommendation was the licensed-medicine archetype with a mandatory licence-ended qualifier; the lead engineer recorded the investigational value on 22 September 2026.
Is sermorelin prohibited in sport?
Yes. Section S2.2.4 of the Prohibited List shown as the latest version on the WADA site on 21 September 2026 names growth hormone-releasing hormone and its analogues, giving CJC-1293, CJC-1295, sermorelin and tesamorelin as examples. Class S2 is prohibited at all times.

References

  1. 1.Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs (1999). doi:10.2165/00063030-199912020-00007 PMID 18031173 · accessed 2026-09-21
  2. 2.SERMORELIN ACETATE (CHEMBL1201490). ChEMBL, EMBL-EBI (2026). https://www.ebi.ac.uk/chembl/api/data/molecule/CHEMBL1201490.json · accessed 2026-09-21
  3. 3.P01286 SLIB_HUMAN Somatoliberin. UniProt Consortium (2026). https://rest.uniprot.org/uniprotkb/P01286.json · accessed 2026-09-21
  4. 4.SERMORELIN (UNII 89243S03TE) - Global Substance Registration System. FDA / NCATS GSRS (2026). https://gsrs.ncats.nih.gov/api/v1/substances/search?q=89243S03TE · accessed 2026-09-21
  5. 5.Drugs@FDA: GEREF (sermorelin acetate), NDA 019863. US Food and Drug Administration (2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863 · accessed 2026-09-21
  6. 6.Drugs@FDA: GEREF (sermorelin acetate), NDA 020443. US Food and Drug Administration (2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443 · accessed 2026-09-21
  7. 7.Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications (74 FR 23407). Food and Drug Administration, Federal Register (2009). https://www.govinfo.gov/content/pkg/FR-2009-05-19/html/E9-11628.htm · accessed 2026-09-21
  8. 8.Determination That GEREF (Sermorelin Acetate) Injection, 0.5 mg Base/Vial and 1.0 mg Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 mg Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (78 FR 14095). Food and Drug Administration, Federal Register (2013). https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm · accessed 2026-09-21
  9. 9.MHRA Products - search results for 'sermorelin'. Medicines and Healthcare products Regulatory Agency (2026). https://products.mhra.gov.uk/search/?search=sermorelin&page=1 · accessed 2026-09-21
  10. 10.EMA medicines output - medicines report (dataset generated 21/09/2026). European Medicines Agency (2026). https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx · accessed 2026-09-21
  11. 11.DailyMed SPL web service query, drug_name=sermorelin. DailyMed, US National Library of Medicine (2026). https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=sermorelin · accessed 2026-09-21
  12. 12.The Prohibited List (List of Prohibited Substances and Methods in force). World Anti-Doping Agency (2026). https://www.wada-ama.org/en/prohibited-list · accessed 2026-09-21
  13. 13.Sermorelin (CID 16132413). PubChem, NCBI/NLM (2026). https://pubchem.ncbi.nlm.nih.gov/compound/16132413 · accessed 2026-09-21
  14. 14.Knoop A, Thomas A, Fichant E, Delahaut P, Schanzer W, Thevis M. Qualitative identification of growth hormone-releasing hormones in human plasma by means of immunoaffinity purification and LC-HRMS/MS. Anal Bioanal Chem (2016). doi:10.1007/s00216-016-9377-3 PMID 26879649 · accessed 2026-09-21
  15. 15.SERMORELIN ACETATE (UNII 00IBG87IQW) - Global Substance Registration System. FDA / NCATS GSRS (2026). https://gsrs.ncats.nih.gov/api/v1/substances/search?q=00IBG87IQW · accessed 2026-09-21
  16. 16.Sermorelin acetate, UNII-00IBG87IQW (CID 16132412). PubChem, NCBI/NLM (2026). https://pubchem.ncbi.nlm.nih.gov/compound/16132412 · accessed 2026-09-21
  17. 17.Sermorelin acetate hydrate (CID 91820622). PubChem, NCBI/NLM (2026). https://pubchem.ncbi.nlm.nih.gov/compound/91820622 · accessed 2026-09-21
  18. 18.Grossman A, Savage MO, Lytras N, Preece MA, Sueiras-Diaz J, Coy DH, Rees LH, Besser GM. Responses to analogues of growth hormone-releasing hormone in normal subjects, and in growth-hormone deficient children and young adults. Clin Endocrinol (Oxf) (1984). doi:10.1111/j.1365-2265.1984.tb03477.x PMID 6236914 · accessed 2026-09-21
  19. 19.Frohman LA, Downs TR, Heimer EP, Felix AM. Dipeptidylpeptidase IV and trypsin-like enzymatic degradation of human growth hormone-releasing hormone in plasma. J Clin Invest (1989). doi:10.1172/JCI114049 PMID 2565342 · accessed 2026-09-21
  20. 20.Bongers J, Lambros T, Ahmad M, Heimer EP. Kinetics of dipeptidyl peptidase IV proteolysis of growth hormone-releasing factor and analogs. Biochim Biophys Acta (1992). doi:10.1016/0167-4838(92)90317-7 PMID 1353684 · accessed 2026-09-21
  21. 21.Bongers J, Heimer EP, Lambros T, Pan YC, Campbell RM, Felix AM. Degradation of aspartic acid and asparagine residues in human growth hormone-releasing factor. Int J Pept Protein Res (1992). doi:10.1111/j.1399-3011.1992.tb01596.x PMID 1428526 · accessed 2026-09-21
  22. 22.Rivier J, Rivier C, Galyean R, Yammamoto G, Vale W. Potent long-acting growth hormone releasing factor analogues. Ann N Y Acad Sci (1988). doi:10.1111/j.1749-6632.1988.tb26971.x PMID 3133968 · accessed 2026-09-21
  23. 23.Mayo KE. Molecular cloning and expression of a pituitary-specific receptor for growth hormone-releasing hormone. Mol Endocrinol (1992). doi:10.1210/mend.6.10.1333056 PMID 1333056 · accessed 2026-09-21
  24. 24.Rafferty B, Poole S, Clarke R, Schulster D. Growth hormone-releasing factor analogue (hGRF1-29NH2): immunoreactive-GRF plasma levels after intravenous and subcutaneous administration. J Endocrinol (1985). doi:10.1677/joe.0.107r005 PMID 2866222 · accessed 2026-09-21
  25. 25.Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? (editorial). Clin Interv Aging (2006). doi:10.2147/ciia.2006.1.4.307 PMID 18046908 · accessed 2026-09-21
  26. 26.Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, Landy H, Eengrand P, Shah S. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. J Clin Endocrinol Metab (1996). doi:10.1210/jcem.81.3.8772599 PMID 8772599 · accessed 2026-09-21
  27. 27.Vittone J, Blackman MR, Busby-Whitehead J, Tsiao C, Stewart KJ, Tobin J, Stevens T, Bellantoni MF, Rogers MA, Baumann G, Roth J, Harman SM, Spencer RG. Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. Metabolism (1997). doi:10.1016/s0026-0495(97)90174-8 PMID 9005976 · accessed 2026-09-21
  28. 28.Friedman AR, Ichhpurani AK, Brown DM, Hillman RM, Krabill LF, Martin RA, Zurcher-Neely HA, Guido DM. Degradation of growth hormone releasing factor analogs in neutral aqueous solution is related to deamidation of asparagine residues. Replacement of asparagine residues by serine stabilizes. Int J Pept Protein Res (1991). doi:10.1111/j.1399-3011.1991.tb00727.x PMID 1904406 · accessed 2026-09-21
  29. 29.electronic medicines compendium (emc) - search results for 'sermorelin'. Datapharm (emc) (2026). https://www.medicines.org.uk/emc/search?q=sermorelin · accessed 2026-09-21
  30. 30.GOV.UK search API query for 'sermorelin'. GOV.UK (2026). https://www.gov.uk/api/search.json?q=sermorelin&count=10 · accessed 2026-09-21
  31. 31.The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1993, SI 1993/1890. legislation.gov.uk (1993). https://www.legislation.gov.uk/uksi/1993/1890/made · accessed 2026-09-21
  32. 32.21 CFR 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A. eCFR, US Government Publishing Office (2026). https://www.ecfr.gov/api/versioner/v1/full/2026-09-01/title-21.xml?part=216&section=216.23 · accessed 2026-09-21
  33. 33.21 CFR 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness. eCFR, US Government Publishing Office (2026). https://www.ecfr.gov/api/versioner/v1/full/2026-09-01/title-21.xml?part=216&section=216.24 · accessed 2026-09-21
  34. 34.Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (categories 1, 2 and 3), updated May 14, 2026. U.S. Food and Drug Administration (2026). https://www.fda.gov/media/94155/download · accessed 2026-09-21
  35. 35.Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. US Food and Drug Administration (2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks · accessed 2026-09-21
  36. 36.Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. US Food and Drug Administration (2026). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act · accessed 2026-09-21
  37. 37.Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A - Guidance for Industry (January 2025). US Food and Drug Administration, CDER (2025). https://www.fda.gov/media/174456/download · accessed 2026-09-21
  38. 38.FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024: Ipamorelin-related bulk drug substances. US Food and Drug Administration (2024). https://www.fda.gov/media/182088/download · accessed 2026-09-21
  39. 39.Corpas E, Harman SM, Pineyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. J Clin Endocrinol Metab (1992). doi:10.1210/jcem.75.2.1379256 PMID 1379256 · accessed 2026-09-21
For laboratory research use only. This article summarises published literature and regulatory records; it does not describe or recommend any use of a material in or on humans or animals.
Cite this page
Harvard
HelixEVO Labs (2026) Sermorelin: GRF(1-29) identity, evidence and a licence that ended. Available at: https://helixevo.net/knowledge-base/compounds/sermorelin (Accessed: 2026-09-25).
APA
HelixEVO Labs. (2026). Sermorelin: GRF(1-29) identity, evidence and a licence that ended. https://helixevo.net/knowledge-base/compounds/sermorelin
BibTeX
@misc{helixevo-2026-sermorelin-grf-1-29-identity-evidence-an,
  title = {Sermorelin: GRF(1-29) identity, evidence and a licence that ended},
  author = {{HelixEVO Labs}},
  year = {2026},
  howpublished = {\url{https://helixevo.net/knowledge-base/compounds/sermorelin}},
  note = {Reviewed 2026-09-22; accessed 2026-09-25}
}
Revision history
  1. r1 · 2026-09-25 · Initial import