Product Description
Pasireotide (Signifor(®)) is a new subcutaneous somatostatin analogue that acts via somatostatin receptors to inhibit the secretion of corticotropin from the pituitary adenoma in patients with Cushing's disease. Pasireotide has a receptor binding profile that is distinct from that of other somatostatin analogues, binding with high affinity to somatostatin receptor subtype 5, which is strongly over expressed in corticotroph adenoma cells. Pasireotide is the first pituitary-directed agent to be approved for use in Cushing's disease. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/23605695/)
Mechanisms of Action: IGF Inhibitor,GHRH Inhibitor
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Intramuscular
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Malaysia | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, Bulgaria, France, Italy, Spain, Switzerland, United States, Unknown Location
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Acromegaly
Phase 2: Carcinoid Tumor|Hypoglycemia|Neuroendocrine Tumors|Oncology Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
SOM230-RECAG-CL-0576 | P2 |
Not yet recruiting |
Unknown |
2026-02-28 |
|
PASIPHY | P2 |
Recruiting |
Hypoglycemia |
2025-04-01 |
|
PASIREOCHIP | P2 |
Active, not recruiting |
Oncology Unspecified |
2023-04-10 |
|
MCC-16438 | P2 |
Completed |
Neuroendocrine Tumors|Carcinoid Tumor |
2021-10-06 |