Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Phenelzine · 1 trial · 1 indication
Tyramine sensitivity factor (TSF) is the ratio of Tyr30 in Period 1 over Tyr30 in Period 3. Tyr30 is defined as the tyramine dose required to increase systolic blood pressure (SBP) by at least 30 mm Hg from daily defined baseline in three consecutive measurements within 4 hours after tyramine dosing.
| Arm | Type | Description |
|---|---|---|
| Phenelzine | ACTIVE_COMPARATOR | Following tyramine challenging in Period 1, eligible subjects randomly assigned to Phenelzine arm are receiving Phenelzine placebo BID plus ozanimod placebo QD from Days 11 to 31, then receiving Phenelzine 15mg BID plus ozanimod placebo QD from Days 32 to 38. Subjects receive second tyramine challenge from Day 39 to up to Day 49 |
| Placebo | PLACEBO_COMPARATOR | Following tyramine challenging in Period 1, eligible subjects randomly assigned to Placebo arm are receiving Phenelzine placebo BID plus ozanimod placebo QD from Days 11 to 38. Subjects receive second tyramine challenge from Day 39 to up to Day 49 |
| ozanimod | EXPERIMENTAL | Following tyramine challenging in Period 1, eligible subjects randomly assigned to ozanimod arm are receiving Phenelzine placebo BID plus ozanimod 1.84mg QD from Days 11 to 38, including dose escalation days. Subjects receive second tyramine challenge from Day 39 to up to Day 49 |
| Name | Type | Description |
|---|---|---|
| Phenelzine | DRUG | Phenelzine |
| Tyramine | DRUG | Tyramine |
| Phenelzine placebo | DRUG | Phenelzine placebo |
| ozanimod placebo | DRUG | ozanimod placebo |
| ozanimod | DRUG | ozanimod |
Inclusion Criteria: 1. Subject is a man or non-pregnant, non-lactating woman, ages 25 to 55 years, inclusive. 2. Female subjects must meet at least 1 of the following criteria: * Negative serum pregnancy test at Screening and Day -1 (WOCBP only). * Postmenopausal (defined as 2 years after th...
Phenelzine is a small molecule drug that acts as an inhibitor of the enzymes MAOA and MAOB. It is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The compound is identified in chemical databases under the ChEMBL ID CHEMBL1089.
Phenelzine targets MAOA and MAOB, two monoamine oxidase enzymes. By inhibiting these targets, phenelzine belongs to the inhibitor class of small molecule therapeutics. This mechanism of action distinguishes it at the molecular level from drugs that act on other enzyme families or receptor targets.
Phenelzine is developed by Bristol-Myers Squibb Company, a pharmaceutical company that trades on the public market under the ticker symbol BMY. The company is the sponsor associated with the clinical development program for this MAOA and MAOB inhibitor.
Phenelzine is in Phase 1 clinical development. It is an investigational small molecule and is not described as approved. The program has one recorded trial, which has completed, and no currently active trials. The single completed study enrolled 92 participants.
Phenelzine has been studied in one completed Phase 1 trial, NCT03694119, titled a drug-drug interaction study of ozanimod with tyramine to evaluate the effect on pressor response. The trial enrolled 92 healthy volunteers in the United States, was randomized, double blind, and placebo controlled, and included participants aged 25 years and older.
No, phenelzine is not a biomarker-selected therapy. Its completed Phase 1 trial, NCT03694119, enrolled healthy volunteers rather than patients chosen by a biomarker, and the study was randomized, double blind, and placebo controlled with 92 participants.