Product Description
Dienogest is an oral progestin that has been investigated extensively in the treatment of endometriosis. Danazol is an androgenic steroid that is effective in treating the signs and symptoms of endometriosis, but its use is limited by adverse effects on lipid metabolism and by weight gain, edema, acne, vaginal dryness, hot flushes, oily skin, hirsutism, liver toxicity, and breast atrophy (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3140813/)
Mechanisms of Action: PR Agonist
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 | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | 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 | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Contraception | Pregnancy Outcomes | Injuries/wounds Unspecified
Known Adverse Events: Headache Disorders | Migraine Disorders | Headache | Pain Unspecified
Company: Elanco Animal Health
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, India, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Adenomyosis|Contraception|Hirsutism
Phase 1: Acute Respiratory Distress Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| LPRI424/303 | P3 |
Completed |
Contraception |
2023-06-30 |
63% |
| 2021-002178-17 | P3 |
Active, not recruiting |
Hirsutism |
2023-04-27 |
|
| 2019-001876-12 | P3 |
Completed |
Contraception |
2022-05-26 |
|
| HP8833-01 | P1 |
Completed |
Acute Respiratory Distress Syndrome |
2022-03-22 |
53% |
| HP8833-01 | P1 |
Completed |
Acute Respiratory Distress Syndrome |
2022-03-22 |
53% |