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PRA-027 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PRA-027 | DRUG | PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days |
Inclusion Criteria: Inclusion Criteria - All Women * Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility. Inclusion Criteria - Cycling Women * Aged 18 to 45 years, must not be breastfee...
PRA-027 is an investigational small molecule being developed for uterine leiomyomata, also known as fibroids. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in healthy female volunteers to assess its safety, tolerability, and pharmacokinetics.
PRA-027 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in healthy female volunteers.
PRA-027 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total enrollment of 48 participants.
PRA-027 has completed three Phase 1 clinical trials: NCT00427544, NCT00444704, and NCT00543790. These trials studied the drug in healthy female volunteers in the United States and Japan, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics.
PRA-027 is the primary name for this investigational drug. No alternative names have been disclosed in the available clinical trial information.