Product Description
Mecasermin (recombinant human insulin-like growth factor-I [IGF-I]) is approved in the US for the long-term treatment of growth failure in children with severe primary IGF-I deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH, and in the EU for the long-term treatment of growth failure in children and adolescents with severe primary IGF-I deficiency. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/18481900/)
Mechanisms of Action: IGF Inhibitor
Novel Mechanism: No
Modality: Coagulation Factor
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Canada | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Taiwan | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Ipsen
Company Location: BOULOGNE BILLANCOURT CEDEX I0 92650
Company CEO: David Loew
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: Hypopituitarism
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2019-000843-29 | P2 |
Active, not recruiting |
Hypopituitarism |
2020-11-30 |
|
| 2019-000844-81 | P3 |
Active, not recruiting |
Hypopituitarism |
2019-06-15 |