Sermorelin

Also known as: Geref

Approved, discontinued

Last verified: October 30, 2026

At a glance

FDA approval Approved, discontinued 2 applications
Randomized controlled trials 1 of 35 publications on PubMed
Registered clinical trials 27 1 active
Adverse event reports 59 36 classified as serious
  • Sermorelin was approved by the FDA (Geref, December 28, 1990), but the products are no longer marketed.
  • PubMed lists 35 publications mentioning it, including 1 randomized controlled trial and 0 animal-only studies.
  • ClinicalTrials.gov lists 27 registered studies testing it (1 active).
  • FDA's adverse event system (FAERS) holds 59 reports mentioning it; 36 classified as serious. Reports do not prove causation.

Research topics

  • Growth Hormone-Releasing Hormone 17
  • Doping in Sports 8
  • Insulin-Like Growth Factor I 8
  • Growth Hormone 7
  • Human Growth Hormone 7
  • Substance Abuse Detection 5
  • Performance-Enhancing Substances 4
  • Tandem Mass Spectrometry 4
  • Chromatography, Affinity 3
  • Chromatography, High Pressure Liquid 3

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA019863 GEREF Approved, discontinued December 28, 1990 EMD SERONO
NDA020443 GEREF Approved, discontinued September 26, 1997 EMD SERONO INC

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 35
  • Human (MeSH) 28
  • Animal only 0
  • Clinical trials 4
  • Randomized controlled trials 1
  • Systematic reviews & meta-analyses 0
  • Case reports 1
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
27
Active
1
With posted results
11

Conditions studied

  • Growth Hormone Deficiency 7
  • Abdominal Obesity 3
  • Aging 3
  • Mild Cognitive Impairment 2
  • HIV 2
  • HIV Lipodystrophy 2
  • Lipodystrophy 2
  • HIV Infections 2
  • HIV-1-infection 1
  • Frailty 1
  • Impaired Physical Function 1
  • Non-Alcoholic Fatty Liver Disease 1
Study Status Phase Start
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
NCT06554717 Massachusetts General Hospital
Recruiting Phase 2 July 10, 2025
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
NCT03375788 Massachusetts General Hospital Results posted
Completed Phase 2 January 17, 2019
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
NCT02553603 The University of Texas Medical Branch, Galveston
Completed Phase 1 July 18, 2017
Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers
NCT03031535 Dauntless Pharmaceuticals
Completed Phase 1 Jan 2017
Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response
NCT02736591 Cairo University
Unknown status Phase 3 Jun 2016
Tesamorelin Effects on Liver Fat and Histology in HIV
NCT02196831 Massachusetts General Hospital Results posted
Completed N/A July 1, 2015
Estradiol-Receptor Blockade in Older Men and Women
NCT02271282 Mayo Clinic
Completed Phase 1 Dec 2014
Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
NCT01632592 Massachusetts General Hospital
Withdrawn N/A Jan 2014
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)
NCT02507245 Stefania La Grutta, MD
Completed — Jan 2014
Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
NCT01410799 University of Pennsylvania Results posted
Terminated Phase 2 May 2011
Show 17 more studies
Study Status Phase Start
VRS-317 in Adult Subjects With Growth Hormone Deficiency
NCT01359488 Versartis Inc.
Completed Phase 1 Mar 2011
Effects of Growth Hormone Releasing Hormone in HIV
NCT01263717 Massachusetts General Hospital Results posted
Completed N/A Dec 2010
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
NCT00850564 Massachusetts General Hospital Results posted
Completed N/A Feb 2009
Effects of Short-term Growth Hormone in HIV-infected Patients
NCT00795210 Massachusetts General Hospital Results posted
Completed N/A Feb 2009
Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
NCT00675506 Massachusetts General Hospital Results posted
Completed Phase 2 Jul 2008
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
NCT02012556 Theratechnologies
Completed Phase 1 May 2008
Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
NCT00807365 Johns Hopkins University Results posted
Terminated Phase 2 December 17, 2007
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
NCT00608023 Theratechnologies Results posted
Completed Phase 3 Aug 2007
Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
NCT00324064 Children's Mercy Hospital Kansas City
Completed N/A Jul 2007
Adult Growth Hormone Deficiency and Cardiovascular Risk
NCT00720902 Columbia University Results posted
Terminated Phase 4 Feb 2007
SMART: Somatotrophics, Memory, and Aging Research Trial
NCT00257712 University of Washington
Completed Phase 2 Feb 2006
TH9507 in Patients With HIV-Associated Lipodystrophy
NCT00123253 Theratechnologies
Completed Phase 3 Jun 2005
The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure
NCT00791843 University of Pennsylvania Results posted
Completed Phase 2 Mar 2004
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
NCT01060488 Merck KGaA, Darmstadt, Germany
Completed Phase 3 Jan 2004
Diagnosing Adult Growth Hormone Deficiency
NCT03018886 Helsinki University Central Hospital
Completed N/A May 2001
Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
NCT00000380 University of Washington
Completed N/A Jun 1996
Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
NCT00004332 National Center for Research Resources (NCRR)
Completed — May 1993

All 27 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
59
Serious
36
With death outcome
1

Most reported reactions

  • Pruritus 6
  • Nausea 5
  • Hypersensitivity 4
  • Malaise 4
  • Rash 4
  • Anaphylactic reaction 3
  • Burning sensation 3
  • Erythema 3
  • Hyperhidrosis 3
  • Infection 3
  • Injection site pruritus 3
  • Injection site urticaria 3

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.