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Somatropin (rDNA origin)
Somatropin (rDNA origin) is a Growth hormone (recombinant) Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Growth hormone deficiency in children, Growth hormone deficiency in adults, Short stature associated with Turner syndrome. Also known as: Humatrope, LY137998.
Somatropin is a recombinant human growth hormone that binds to growth hormone receptors to stimulate growth, metabolism, and body composition changes.
Somatropin (rDNA origin) is a protein-based growth hormone receptor agonist used to treat conditions such as growth hormone disorders, growth hormone deficiency, and growth disorder. It is administered via injection and has been studied in clinical trials for various indications, including arthritis, juvenile rheumatoid arthritis, and Crohn's disease.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Somatropin (rDNA origin) |
|---|---|
| Also known as | Humatrope, LY137998 |
| Sponsor | Eli Lilly and Company |
| Drug class | Growth hormone (recombinant) |
| Target | Growth hormone receptor (GHR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Somatropin mimics endogenous human growth hormone by activating growth hormone receptors on target tissues, promoting linear growth in children, increasing lean body mass, decreasing fat mass, and enhancing metabolic function. It stimulates insulin-like growth factor 1 (IGF-1) production, which mediates many of the anabolic and growth-promoting effects of growth hormone.
Approved indications
- Growth hormone deficiency in children
- Growth hormone deficiency in adults
- Short stature associated with Turner syndrome
- Chronic kidney disease-related growth failure
Common side effects
- Injection site reactions
- Headache
- Hyperglycemia
- Arthralgia
- Carpal tunnel syndrome
- Fluid retention
Key clinical trials
- Growth Hormone Administration and the Human Immune System (PHASE1)
- Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery (PHASE4)
- Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS) (PHASE4)
- rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency (PHASE2)
- Growth Hormone Replacement Therapy for Retried Professional Football Players (PHASE2)
- IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
- Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears (PHASE2)
- Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq (PHASE3)
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:
- Somatropin (rDNA origin) CI brief — competitive landscape report
- Somatropin (rDNA origin) updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Somatropin (rDNA origin)
What is Somatropin (rDNA origin)?
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Who makes Somatropin (rDNA origin)?
Is Somatropin (rDNA origin) also known as anything else?
What drug class is Somatropin (rDNA origin) in?
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What does Somatropin (rDNA origin) target?
Related
- Drug class: All Growth hormone (recombinant) drugs
- Target: All drugs targeting Growth hormone receptor (GHR)
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Endocrinology
- Indication: Drugs for Growth hormone deficiency in children
- Indication: Drugs for Growth hormone deficiency in adults
- Indication: Drugs for Short stature associated with Turner syndrome
- Also known as: Humatrope, LY137998
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing