Ozmosi | Dienogest Drug Profile
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Dienogest

Alternative Names: dienogest, visanne, natazia, bay86-5258
Clinical Status: Inactive
Latest Update: 2025-10-02
Latest Update Note: Clinical Trial Update

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: *

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: None

Known Adverse Events: None

Company: Bayer
Company Location:
Company CEO: Werner Baumann
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Dienogest

Countries in Clinic: United States

Active Clinical Trial Count: 2

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Contraception|Hirsutism

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2021-002178-17

2021-002178-17

P3

Completed

Hirsutism

2023-12-05

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status

NCT03945513

LPRI424/303

P3

Completed

Contraception

2023-06-30

17%

2023-11-15

Primary Endpoints|Study Completion Date|Treatments|Trial Status