Product Description
Vosoritide treatment has safe and persistent growth-promoting effects in children with achondroplasia treated daily for two years. Vosoritide, an analog of C-type natriuretic peptide, stimulates endochondral bone growth and is in development for the treatment of achondroplasia. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/34341520/)
Mechanisms of Action: FGF3 Antagonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Croatia | Czech | Estonia | European Medicines Agency | Finland | France | Germany | Hungary | Iceland | Ireland | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Poland | Portugal | Romania | Slovakia | Slovenia | Spain | Sweden | United States
Approved Indications: Achondroplasia
Known Adverse Events: Erythema | Urticaria | Enteritis | Gastroenteritis | Arthralgia
Company: Biomarin
Company Location: NOVATO CA 94949
Company CEO: Jean-Jacques Bienaimé
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, France, Germany, Italy, Japan, Spain, Turkey, United Kingdom, United States
Active Clinical Trial Count: 17
Highest Development Phases
Phase 3: Achondroplasia|Dwarfism|Limb Deformities, Congenital|Lordosis|Other
Phase 2: Gonadal Dysgenesis|Noonan Syndrome|Turner Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCT03989947 | P2 |
Active, not recruiting |
Achondroplasia |
2038-05-01 |
|
| NCT03424018 | P3 |
Active, not recruiting |
Achondroplasia |
2031-06-01 |
|
| 111-302 | P3 |
Unknown Status |
Achondroplasia |
2030-12-31 |
|
| ACH | P2 |
Active, not recruiting |
Achondroplasia |
2027-12-01 |