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Small for Gestational Age

4
Pipeline Programs
4
Companies
7
Clinical Trials
2 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
1
3
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Pfizer
GENOTROPINApproved
somatropin
Pfizer
injection1995
27M Part D
Pfizer
GENOTROPIN PRESERVATIVE FREEApproved
somatropin
Pfizer
injection1995

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
1 program
1
SomatropinN/A1 trial
Active Trials
NCT00793325Completed920Est. Dec 2012
Sandoz
SandozAustria - Kundl
1 program
1
OmnitropePhase 41 trial
Active Trials
NCT00537914Completed278Est. Mar 2022
Amoytop Biotech
Amoytop BiotechChina - Xiamen
1 program
1
somatropinPhase 35 trials
Active Trials
NCT07614152Not Yet Recruiting84Est. Feb 2030
NCT07551804Not Yet Recruiting36Est. Jun 2028
NCT07309562Recruiting141Est. May 2028
+2 more trials
Novartis
NovartisBASEL, Switzerland
1 program
OmnitropePHASE_4

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
SandozOmnitrope
Amoytop Biotechsomatropin
Amoytop Biotechsomatropin
Amoytop Biotechsomatropin
Amoytop Biotechsomatropin
Amoytop Biotechsomatropin
PfizerSomatropin

Clinical Trials (7)

Total enrollment: 2,193 patients across 7 trials

Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

Start: Feb 2008Est. completion: Mar 2022278 patients
Phase 4Completed

The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature

Start: Jun 2026Est. completion: Feb 203084 patients
Phase 3Not Yet Recruiting

The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age

Start: Jan 2026Est. completion: May 2028141 patients
Phase 3Recruiting

The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature

Start: Apr 2025Est. completion: Jun 2028300 patients
Phase 3Recruiting

Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children

Start: Dec 2018Est. completion: Jul 2023434 patients
Phase 2/3Completed

Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency

Start: May 2026Est. completion: Jun 202836 patients
Phase 2Not Yet Recruiting

Long Term Use of Somatropin in Patients Small for Gestational Age

Start: Feb 2009Est. completion: Dec 2012920 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 2,193 patients
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.