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MAXOMAT, biosynthetic growth hormone

Phase 3

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

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, a biosynthetic growth hormone, is used to improve growth in small children with Noonan Syndrome. It is being developed by Sanofi and is currently in Phase 3 clinical development. The drug is intended to address growth deficits associated with this rare genetic condition.

What does MAXOMAT target?

MAXOMAT is a biosynthetic growth hormone, meaning it acts as a replacement for naturally occurring human growth hormone. It works by supplementing growth hormone levels in the body to promote linear growth in children with Noonan Syndrome who have short stature.

Who makes MAXOMAT?

MAXOMAT is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research to evaluate the safety and efficacy of MAXOMAT in treating growth issues associated with Noonan Syndrome.

What phase is MAXOMAT in?

MAXOMAT is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an uncontrolled study involving 36 participants with Noonan Syndrome. The drug is investigational and has not yet been approved by regulatory authorities for commercial use.

What clinical trials is MAXOMAT in?

MAXOMAT has been studied in one clinical trial registered under NCT00452725, titled 'Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome'. This Phase 3 trial was completed in France and enrolled 36 children aged 3 years and older with Noonan Syndrome.

Is MAXOMAT the same as biosynthetic growth hormone?

Yes, MAXOMAT is a biosynthetic growth hormone. It is a laboratory-produced version of human growth hormone, designed to mimic the natural hormone's effects. This makes it distinct from growth hormones derived from human or animal sources, offering a more consistent and controlled treatment option.