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Serostim®
Serostim is a recombinant human growth hormone that stimulates anabolic processes and increases lean body mass in patients with HIV-associated wasting.
Serostim is a recombinant human growth hormone that stimulates anabolic processes and increases lean body mass in patients with HIV-associated wasting. Used for HIV-associated wasting or cachexia in patients with HIV infection and low body weight.
At a glance
| Generic name | Serostim® |
|---|---|
| Also known as | Recombinant human growth hormone (r-hGH), mammalian cell-derived recombinant human growth hormone, r hGH, recombinant human growth hormone (r-hGH) |
| Sponsor | EMD Serono |
| Drug class | Growth hormone (recombinant human somatropin) |
| Target | Growth hormone receptor (GHR) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Serostim (somatropin) is a synthetic form of human growth hormone that binds to growth hormone receptors, promoting protein synthesis, lipolysis, and increased lean body mass while reducing fat mass. In HIV-infected patients with wasting syndrome, it helps reverse the catabolic state and restore body composition. The drug enhances nitrogen retention and metabolic rate, counteracting the muscle-wasting effects of advanced HIV disease.
Approved indications
- HIV-associated wasting or cachexia in patients with HIV infection and low body weight
Common side effects
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Carpal tunnel syndrome
- Edema (fluid retention)
- Hyperglycemia
- Injection site reactions
Key clinical trials
- A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (PHASE3)
- Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders (PHASE3)
- A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD) (PHASE1, PHASE2)
- A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS) (PHASE1, PHASE2)
- A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics (PHASE2)
- A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
- Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone
- Effects of Ketone Bodies on Insulin Sensitivity (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Serostim® CI brief — competitive landscape report
- Serostim® updates RSS · CI watch RSS
- EMD Serono portfolio CI