Last reviewed 2026-05-23 · How we verify

somatropine

Sanofi · Phase 3 active Small molecule ✓ Verified May 2026

somatropine is a Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Growth retardation, Pituitary dwarfism, Prader-Willi syndrome.

Somatropine is a growth hormone receptor agonist, classified as an agonist drug. It is used to treat various conditions, including anorexia nervosa, growth hormone deficiency, delayed puberty, interruption of growth, osteopenia with failure of acquisition of bone mass, and growth hormone deficiency.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	somatropine
Sponsor	Sanofi
Target	Growth hormone receptor
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

Growth retardation
Pituitary dwarfism
Prader-Willi syndrome
Severe growth hormone deficiency in adulthood
Turner syndrome

Common side effects

No common side effects on file.

Key clinical trials

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:

somatropine CI brief — competitive landscape report
somatropine updates RSS · CI watch RSS
Sanofi portfolio CI

Frequently asked questions about somatropine

What is somatropine?

somatropine is a Small molecule drug developed by Sanofi, indicated for Growth retardation, Pituitary dwarfism, Prader-Willi syndrome.

What is somatropine used for?

somatropine is indicated for Growth retardation, Pituitary dwarfism, Prader-Willi syndrome, Severe growth hormone deficiency in adulthood, Turner syndrome.

Who makes somatropine?

somatropine is developed by Sanofi (see full Sanofi pipeline at /company/sanofi).

What development phase is somatropine in?

somatropine is in Phase 3.

What does somatropine target?

somatropine targets Growth hormone receptor.

Target: All drugs targeting Growth hormone receptor
Manufacturer: Sanofi — full pipeline
Therapeutic area: All drugs in Other
Indication: Drugs for Growth retardation
Indication: Drugs for Pituitary dwarfism
Indication: Drugs for Prader-Willi syndrome

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing