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somatropine

Phase 3

Growth Hormone Deficiency | Small molecule | Endocrine |Sanofi|Trials Updated: Feb 12, 2009

somatropine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2007

somatropine target and mechanism

Molecular targetGHR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

somatropine clinical trials

somatropine · 1 trial · 1 indication

Phase 3 1
NCT00476385Practicability and Acceptability of Stylomax® in ChildrenGrowth Hormone Deficiency
COMPLETED12 Analytics
PHASE3COMPLETED
Practicability and Acceptability of Stylomax® in Children
Growth Hormone DeficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

practicability/acceptability of the Stylomax pen
at each visit

Secondary Endpoints

tolerability : pain (evaluation on pain scale)
at each visit
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
somatropineEXPERIMENTAL -

Interventions

NameTypeDescription
somatropineDRUGsubcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg
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Eligibility Criteria

Age Range3 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children over 3 years of age with growth hormone deficiency, requiring treatment with MAXOMAT® according to the criteria of the MA. Exclusion Criteria: * The above information is not intended to contain all considerations relevant to a patient's potential participation in a ...

Countries:France
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Frequently asked questions about somatropine

What is somatropine used for?

Somatropine is used for Growth Hormone Deficiency. It is an endocrine therapy developed by Sanofi and is in Phase 3 clinical development. It is a small molecule rather than a recombinant protein product.

What does somatropine target?

Somatropine targets GHR, the growth hormone receptor, and acts as an agonist at that receptor. Agonist activity at GHR is the mechanism by which the drug is intended to address Growth Hormone Deficiency.

Who makes somatropine?

Somatropine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development program for this Growth Hormone Deficiency candidate.

What phase is somatropine in?

Somatropine is in Phase 3 clinical development for Growth Hormone Deficiency. It is an investigational agent and is not described as approved. Its development is led by Sanofi.

What clinical trials is somatropine in?

Somatropine has been studied in one completed Phase 3 trial, NCT00476385, titled Practicability and Acceptability of Stylomax in Children. That trial enrolled 12 participants in France, included children aged 3 years and older, and was uncontrolled and not randomized.

Is somatropine the same as Stylomax?

Somatropine is associated with the name Stylomax, which appears in the title of its Phase 3 trial in children with Growth Hormone Deficiency. Readers searching for Stylomax are looking at the same development program as somatropine.