Data updated: May 26, 2026
GENOTROPIN (somatropin)
Trial Activity: Declining 1 active trials
Endocrine
Approved 1995-08-24
GENOTROPIN is indicated for the treatment of Growth Hormone Deficiency; Prader-Willi Syndrome; Small for Gestational Age; Turner Syndrome; Idiopathic Short Stature.
Source: FDA Label • PHARMACIA
How GENOTROPIN Works
GENOTROPIN is a recombinant human growth hormone that is therapeutically equivalent to the hormone naturally produced by the pituitary gland. In pediatric patients, the medication stimulates linear growth and normalizes concentrations of Insulin-like Growth Factor-I (IGF-I). In adults with growth hormone deficiency, the drug works to reduce fat mass, increase lean body mass, and induce beneficial changes in lipid metabolism. By replacing deficient levels of endogenous hormone, it restores biological processes necessary for growth and metabolic regulation.
Development Insights
Pfizer conducting 2 trials (15%)
10 indications explored (Broad Platform)
→ growth hormone deficiency (5 trials)
→ adult growth hormone deficiency (2 trials)
→ iss (1 trials)
6
Indications
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Phase 3 Trials
2
Priority Reviews
30
Years on Market
Details
- Status
- Prescription
- First Approved
- 1995-08-24
- Patent Cliff
- 2008
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GENOTROPIN Approval History
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New Indication
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Label Update
130 FDA actions from 1995 to 2025 · 5 indication expansions
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Label
Dec 1995 SUPPL
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Aug 1995 ORIGINAL
Update
What GENOTROPIN Treats
5 indicationsGENOTROPIN is approved for 5 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
- Prader-Willi Syndrome
- Small for Gestational Age
- Turner Syndrome
- Idiopathic Short Stature
Source: FDA Label
GENOTROPIN Competitive Set
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Direct competitors
1
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Indication competitors
8
Same indication, different mechanism — what else might this patient receive?
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Drugs Similar to GENOTROPIN
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
40 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05690386 | ASND0034 | Ph 2 | active not recruiting | A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome |
| NCT07226089 MISSION | 0081-24-RMC | Ph 3 | recruiting | Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature. |
| NCT04867317 GRIT | 2018 | Ph 3 | recruiting | Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) |
| NCT02968004 results posted | CP-4-006 | Ph 3 | completed | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children |
| NCT05382637 results posted | STUDY00000211 | Ph 2 | active not recruiting | Growth Hormone in a Patient With a Dominant-Negative GHR Mutation |
| NCT03554265 results posted | 17-0313 | Ph 3 | completed | Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy |
| NCT04615273 foresiGHt results posted | TCH-306 2020-000929-42 | Ph 3 | completed | A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency |
| NCT01529944 | GHNOO-3680 2008-004535-38 | Ph 3 | completed | Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658 |
| NCT03123913 STARFISH results posted | 1R01NS095813-01 | Ph 1 | completed | Study of Testosterone and rHGH in FSHD |
| NCT03038594 | 19-0298 / 15-0192 W81XWH-15-1-0143 | Ph 2, Ph 3 | completed | Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients |
| NCT02597660 | HUM00107019 | Ph 2 | withdrawn | A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy |
| NCT02092077 | TV1106-IMM-20001 2013-004468-69 | Ph 2 | terminated | A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children |
| NCT03831880 results posted | C0311002 2018-000918-38 | Ph 3 | completed | Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD |
| NCT03874013 results posted | CP-4-009 | Ph 3 | completed | Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency |
| NCT01973244 | NN8640-4042 2013-000013-20, U1111-1138-2206 | Ph 1 | completed | A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency |
| NCT02229851 REAL 1 results posted | NN8640-4054 2013-002892-16, U1111-1145-0211 | Ph 3 | completed | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. |
| NCT01927861 results posted | GHLIQUID-4020 U1111-1131-5892, JapicCTI-132336 | Ph 3 | completed | Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome |
| NCT02382939 REAL 2 results posted | NN8640-4043 2014-000290-39, U1111-1152-3664 | Ph 3 | completed | A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency |
| NCT03309891 | GX-H9-003 | Ph 2 | completed | Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency |
| NCT04085224 | LG-HGCL010 | Ph 1 | completed | 6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers |
| NCT01298960 FUNDEX001 | FUNDEX001 2010-022151-32 | Ph 2 | terminated | Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients |
| NCT01592500 results posted | CP-4-004 2011-004553-60 | Ph 2 | completed | Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children |
| NCT02420353 results posted | HUM00087702 IND Exemption 123189 | Ph 2 | completed | Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears |
| NCT02204163 | LG-HGCL007 | Ph 3 | completed | Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome |
| NCT02311894 results posted | ML29543 | Ph 4 | completed | A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency |
| NCT03015909 | LG-HGCL008 | Ph 4 | completed | Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. |
| NCT01699308 GH | Pfizer/WS935852 09.0874-F1V | Ph 1 | completed | Growth Hormone and Brain Functioning After Traumatic Brain Injury |
| NCT02946606 | GX-H9-002 | Ph 2 | completed | A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9 |
| NCT01778023 results posted | GH-3899 U1111-1125-4790, 2015-002613-30 | Ph 3 | completed | Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature |
| NCT01401244 | GH-3939 U1111-1121-3640 | Ph 1 | completed | Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers |
| NCT00936403 | NN8630-1824 2008-008240-25 | Ph 2 | completed | A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone |
| NCT01822340 HM10560A | 11-HM10560A-201 | Ph 2 | completed | Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients |
| NCT01397500 | CS/Muenchen 02 | Ph 2 | terminated | Hormone Treatment in Growth Hormone and Testosterone Deficient Patients |
| NCT00943995 | 907-M02R | Ph 3 | completed | Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis |
| NCT01512095 | GH-3958 2012-003381-40, U1111-1122-9661 | Ph 1 | withdrawn | Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers |
| NCT00630487 IGHD results posted | A6281282 | Ph 3 | terminated | Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency |
| NCT01440686 HL-032 | HGR10I_1 | Ph 1 | completed | Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers |
| NCT00884000 | FE999905 CS07 2008-004849-28 | Ph 3 | completed | A Study of Zomacton in Children With Growth Hormone Deficiency |
| NCT00625872 SGA-POWER results posted | A6281283 | Ph 3 | terminated | Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy |
| NCT00555009 results posted | A6281289 | Ph 4 | terminated | Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury |
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GENOTROPIN FDA Label Details
Indications & Usage
FDA Label (PDF)GENOTROPIN is indicated for the treatment of Growth Hormone Deficiency; Prader-Willi Syndrome; Small for Gestational Age; Turner Syndrome; Idiopathic Short Stature.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment