Recent Updates
Recently added Catalysts

somatropin, rDNA origin

Phase 3

Growth Disorder | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: Mar 9, 2007

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

somatropin, rDNA origin · 1 trial · 1 indication

Phase 3 1
NCT00191074Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short StatureGrowth Disorder
COMPLETED11 Analytics
PHASE3COMPLETED
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Growth Disorder
NCT0019107411
Unlock trial analytics

Study Endpoints

Primary Endpoints

Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
laboratory blood draws.

Secondary Endpoints

Not applicable for Amendment (g).
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
somatropin, rDNA origin, for injectionDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range9 Years to 16 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Participation in core, blinded phase and ability to be contacted by investigators. For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to disco...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Growth Disorders 4 trials (matched to "Growth Disorder")

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO2PHASE3Somapacitan
Ascendis Pharma A/SASND1PHASE3Lonapegsomatropin, Somatropin Pen Injector
Unlock Competitive Intelligence

Frequently asked questions about somatropin, rDNA origin

What is Somatropin used for?

Somatropin is a growth hormone treatment in Phase 3 clinical development for idiopathic short stature, small for gestational age, failure to thrive, growth disorder, growth hormone deficiency, and Turner syndrome. It is being studied for use in children and adults with these endocrine-related growth conditions.

Who makes Somatropin?

Somatropin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting Phase 3 clinical trials to evaluate the treatment for various growth disorders.

What phase is Somatropin in?

Somatropin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials have been completed, with no active trials currently ongoing for this treatment.

What clinical trials is Somatropin in?

Somatropin has been studied in four completed Phase 3 clinical trials. These include NCT00190658 in patients with SHOX deficiency and Turner syndrome, NCT00191074 in idiopathic short stature, NCT00191360 in adult growth hormone deficiency, and NCT00191529 in short children born small for gestational age.

Is Somatropin the same as growth hormone?

Somatropin is a form of growth hormone used in clinical trials for various growth disorders. It is being investigated as a treatment for conditions such as idiopathic short stature, Turner syndrome, and growth hormone deficiency, among others.