Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DR-1021 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DR-1021 | DRUG | 1 tablet daily |
Inclusion Criteria: * Premenopausal * Not pregnant or breastfeeding * Sexually active at risk of pregnancy Exclusion Criteria: * Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * Smoking \> 10 cigarettes per day
DR-1021 is an investigational small-molecule oral contraceptive being developed by Teva Pharmaceutical Industries Limited. It is a low-dose 28-day oral contraceptive regimen studied for the prevention of pregnancy in women. DR-1021 is in Phase 3 clinical development and has not been approved by the FDA.
DR-1021 is being studied for contraception, meaning the prevention of pregnancy in women. The Phase 3 trial enrolled healthy female volunteers aged 18 years and older. Its development sits within the endocrine therapeutic area, and the drug remains investigational rather than approved for prescribing.
DR-1021 is being developed by Teva Pharmaceutical Industries Limited, which trades on the Nasdaq under the ticker TEVA. Teva is the sponsor of the Phase 3 study evaluating the low-dose 28-day oral contraceptive. No other developer or partner is identified for this asset.
DR-1021 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently listed as active. Because the program is still in clinical development, DR-1021 is investigational and has not been approved by the FDA for contraceptive use.
DR-1021 has been evaluated in one Phase 3 trial, NCT00362479, titled an open-label study to evaluate the safety and efficacy of a low-dose 28-day oral contraceptive. The trial was completed, enrolled 1,347 participants, was conducted in the United States, and used an uncontrolled design.
The Phase 3 trial NCT00362479 was an open-label, uncontrolled study of a low-dose 28-day oral contraceptive. It enrolled 1,347 healthy female volunteers aged 18 years and older in the United States. The study was not randomized and not double-blind, and it has been completed.