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MAXOMAT, biosynthetic growth hormone

Phase 3

Noonan Syndrome | Small molecule | Rare Disease |Sanofi|Last Updated: Oct 5, 2010

Target and mechanism

ModalitySmall molecule

Also known as MAXOMAT ®, biosynthetic growth hormone

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

MAXOMAT, biosynthetic growth hormone · 1 trial · 1 indication

Phase 3 1
NCT00452725Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's SyndromeNoonan Syndrome
COMPLETED36 Analytics
PHASE3COMPLETED
Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome
Noonan SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of height : gain in height and rate of growth
at each visit (every 3 months) or every 6 months

Secondary Endpoints

Clinical and laboratory test safety
every 6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
MAXOMAT ®, biosynthetic growth hormoneDRUG2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration
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Eligibility Criteria

Age Range3 Years to 15 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children and adolescents with Noonan's syndrome with a height \< -2 SD and no progressive cardiopathy Exclusion Criteria: * Age \< 3 years * Height ≥ -2 SD The above information is not intended to contain all considerations relevant to a patient's potential participation in...

Countries:France
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Frequently asked questions about MAXOMAT, biosynthetic growth hormone

What is MAXOMAT used for in Noonan Syndrome?

MAXOMAT is a biosynthetic growth hormone studied for treating short stature in children with Noonan Syndrome, a rare genetic condition. It was evaluated in a Phase 3 trial of 36 children aged 3 years and older in France to assess its effect on growth.

Who makes MAXOMAT?

MAXOMAT is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the biosynthetic growth hormone in pediatric Noonan Syndrome.

What phase is MAXOMAT in?

MAXOMAT has been studied in a Phase 3 clinical trial in Noonan Syndrome. The trial, NCT00452725, is listed as completed. MAXOMAT is an investigational biosynthetic growth hormone and is not described as approved for this indication.

What clinical trials is MAXOMAT in?

MAXOMAT has been evaluated in one clinical trial, NCT00452725, titled Effect of MAXOMAT on the Growth of Small Children to NOONAN's Syndrome. The Phase 3 study enrolled 36 participants in France, included both sexes, and had a minimum age of 3 years. It is completed.

Is MAXOMAT the same as biosynthetic growth hormone?

Yes. MAXOMAT is also written as MAXOMAT and referred to as biosynthetic growth hormone, so searches using either name point to the same product developed by Sanofi for Noonan Syndrome.

How was the MAXOMAT Noonan Syndrome trial designed?

The Phase 3 trial NCT00452725 was an uncontrolled study, not randomized and not double blind, enrolling 36 children with Noonan Syndrome in France. Participants were 3 years of age or older, and the study is completed.