Data updated: May 26, 2026
SEROSTIM (somatropin)
Endocrine
Approved 1996-08-23
SEROSTIM is indicated for the treatment of Cachexia; Wasting.
Source: FDA Label • EMD SERONO
How SEROSTIM Works
Serostim functions as an anabolic and anticatabolic agent by interacting with specific receptors on a variety of cell types, including myocytes, hepatocytes, and adipocytes. These interactions also involve lymphocytes and hematopoietic cells to produce therapeutic effects. While some of these effects are mediated by insulin-like growth factor-1 (IGF-1), the drug also exerts influence through other pathways. This multi-cellular interaction helps the body increase lean mass and improve physical endurance.
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Indications
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Phase 3 Trials
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Priority Reviews
29
Years on Market
Details
- Status
- Prescription
- First Approved
- 1996-08-23
- Patent Cliff
- 2003
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SEROSTIM Approval History
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Original
New Indication
New Form
Label Update
204 FDA actions from 1996 to 2017 · 2 indication expansions
Sep 2014 SUPPL Priority
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Jul 1997 SUPPL Priority
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Aug 1996 ORIGINAL Priority
Update
What SEROSTIM Treats
2 indicationsSEROSTIM is approved for 2 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cachexia
- Wasting
Source: FDA Label
SEROSTIM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
1
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
29 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| NCT00625872 SGA-POWER results posted | A6281283 | Ph 3 | terminated | Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
SEROSTIM FDA Label Details
Indications & Usage
FDA Label (PDF)SEROSTIM is indicated for the treatment of Cachexia; Wasting.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.