At a glance
- Somatropin (recombinant human growth hormone) is an FDA-approved drug, marketed as Humatrope, Nutropin, Bio-tropin, Zomacton, Genotropin, Serostim, Saizen, Norditropin, Zorbtive, Omnitrope (first approval: October 16, 1986).
- PubMed lists 4,058 publications mentioning it, including 488 randomized controlled trials and 234 animal-only studies.
- ClinicalTrials.gov lists 823 registered studies testing it (85 active).
- FDA's adverse event system (FAERS) holds 78,676 reports mentioning it; 22,961 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| BLA019640 | HUMATROPE | Approved, marketed | October 16, 1986 | LILLY |
| BLA020168 | NUTROPIN | Approved, discontinued | November 17, 1993 | GENENTECH |
| BLA019676 | NUTROPIN | Approved, marketed | March 9, 1994 | GENENTECH |
| BLA019774 | BIO-TROPIN, ZOMACTON | Approved, marketed | May 25, 1995 | FERRING |
| BLA020280 | GENOTROPIN, GENOTROPIN PRESERVATIVE FREE | Approved, marketed | August 24, 1995 | PHARMACIA |
| BLA020522 | NUTROPIN AQ, NUTROPIN AQ NUSPIN, NUTROPIN AQ PEN | Approved, marketed | December 29, 1995 | GENENTECH |
| BLA020604 | SEROSTIM, SEROSTIM LQ | Approved, marketed | August 23, 1996 | EMD SERONO |
| BLA019764 | SAIZEN | Approved, marketed | October 8, 1996 | EMD SERONO |
| BLA021148 | NORDITROPIN, NORDITROPIN FLEXPRO, NORDITROPIN NORDIFLEX | Approved, marketed | June 20, 2000 | NOVO NORDISK INC |
| BLA021597 | ZORBTIVE | Approved, marketed | December 1, 2003 | EMD SERONO |
| BLA021426 | OMNITROPE | Approved, marketed | May 30, 2006 | SANDOZ |
| BLA021538 | ACCRETROPIN | Approved, discontinued | January 23, 2008 | EMERGENT |
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
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
- Erratum to "Development and malidation of a mechanism-based Ba/F3-hGHR bioassay for the potency assessment of recombinant human growth hormone" [Anal. Biochem. 720 116237].
- Development and validation of a mechanism-based Ba/F3-hGHR bioassay for the potency assessment of recombinant human growth hormone.
- Recombinant human growth hormone exposure preceding multisystem manifestations in a patient with MT-TL1 m.3243 A > G-related mitochondrial disease: a ten-year case report.
- Skeletal Accrual in Pediatric Growth Hormone Deficiency: A Narrative Review.
- Efficacy and Safety of Lonapegsomatropin in Children With Turner Syndrome: 52-Week Results From the New InsiGHTS Trial.
- A Rare Association of Turner Syndrome, Celiac Disease, and Ulcerative Colitis in a Pediatric Patient: A Case Report.
- Case Report: Case series: growth hormone replacement for severe growth hormone deficiency during BRAF inhibitor therapy in pediatric low-grade glioma: long-term follow-up.
- An assessment of the global usability of quality-of-life questionnaires in children receiving recombinant growth hormone therapy.
- Efficacy of recombinant growth hormone therapy in children born small for gestational age (SGA): a retrospective analysis.
- The changes in health-related quality of life and psychological outcomes in Chinese children with short stature after growth hormone therapy.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 823
- Active
- 85
- With posted results
- 165
Conditions studied
Show 40 more studies
All 823 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 78,676
- Serious
- 22,961
- With death outcome
- 1,774
Most reported reactions
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
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- HUMATROPE
- GENOTROPIN
- Somaderm
- GH
- Age Defiance Pro
- ZOMACTON
- Growth Hormone Drops 2160
- Multi-Potency Growth Hormone Drops 2162
- Omnitrope
- Norditropin
- Skin Liquescence
- Vital Immune Booster
- D-136
- Vital Immune Booster
- Female Liquescence
- Female Liquescence
- Weight Off
- Vital Age Defiance
- Male Balance
- Dr Dale Wellness NU Fem 1 2 3 All In One Topical Homeopathic
- High Vitality Tab
- Vital Skin Hair Nails
- Virility Liquescence
- Young Again
- HGH
- HGH Vitality
- HGH-Pro T020
- HGH
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.