Product Description
Drospirenone is one of several different progestins that are used in birth control pills. Most birth control pills (combination oral contraceptives) combine a synthetic version of the female hormone progesterone (referred to as a progestin) with a synthetic version of the female hormone estrogen. (Sourced from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-drospirenone)
Mechanisms of Action: MCRA Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Bayer
Company Location: LEVERKUSEN 2M D-51368
Company CEO: Werner Baumann
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, Estonia, Finland, Georgia, Japan, Latvia, Poland, Sweden, Thailand, United States
Active Clinical Trial Count: 9
Highest Development Phases
Phase 3: Acute Respiratory Distress Syndrome|Contraception|Endometriosis
Phase 2: Healthy Volunteers
Phase 1: Pulmonary Fibrosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2071240132 | P2 |
Not yet recruiting |
Healthy Volunteers |
2026-01-31 |
|
| jRCT2031210556 | P3 |
Active, not recruiting |
Contraception |
2024-09-30 |
|
| CF113-303 | P3 |
Active, not recruiting |
Contraception |
2024-08-05 |
58% |
| DRE-027-22 | P1 |
Not yet recruiting |
Healthy Volunteers |
2024-04-29 |
12% |
| DRE-026-22 | P1 |
Recruiting |
Healthy Volunteers |
2024-04-04 |
12% |
| IM027-1013 | P1 |
Completed |
Pulmonary Fibrosis |
2023-12-11 |
23% |
| MIT-Es001-C303 | P3 |
Completed |
Contraception|Acute Respiratory Distress Syndrome |
2023-11-24 |
15% |
| 2021-001424-17 | P3 |
Completed |
Endometriosis |
2023-09-25 |
|
| 2019-003002-27 | P3 |
Active, not recruiting |
Contraception |
2023-04-14 |
15% |