Approval Probability
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Adjusted LOA
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Pegvisomant · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Treatment sequence #1 | ACTIVE_COMPARATOR | One 1-mL subcutaneous injection at 30 mg/mL in Period 1 and two 1-mL subcutaneous injections at 15 mg/mL each in Period 2 |
| Treatment sequence #2 | ACTIVE_COMPARATOR | Two 1-mL subcutaneous injections at 15 mg/mL each in Period 1 and one 1-mL SC injection at 30 mg/mL in Period 2 |
| Name | Type | Description |
|---|---|---|
| Pegvisomant | DRUG | - |
Inclusion Criteria: * Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009). Exclusion Criteria: * Switching to other therapeutic methods for acromegaly
Pegvisomant is used for the treatment of acromegaly, a condition of excess growth hormone. It has been studied in a Phase 3 clinical trial for acromegaly in Japan. The drug is also being investigated for bioavailability in healthy subjects.
Pegvisomant is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the developer of this investigational drug for acromegaly.
Pegvisomant is in Phase 3 clinical development for acromegaly. It has completed a Phase 3 trial in Japan with 16 participants. The drug is investigational and not yet approved for marketing.
Pegvisomant has been studied in two completed trials. NCT00143416 is a Phase 3 long-term study in acromegaly patients in Japan. NCT01181973 is a Phase 1 study of safety, tolerability, and relative bioavailability in healthy subjects in Singapore.
Yes, Pegvisomant is also known as B2036-PEG. The Phase 3 clinical trial for acromegaly, NCT00143416, is titled 'Long Term Study With B2036-PEG' and evaluates this drug in patients with acromegaly.