dienogest
Trade name: natazia
Approved
May 6, 2010
Dienogest (Natazia) is a hybrid progestogen that combines properties of both the 19-nortestosterone derivatives and the progesterone derivatives. It is indicated for use by women to prevent pregnancy and for the treatment of heavy menstrual bleeding in women without organic pathology. Dienogest is also approved in Europe, Australia, Malaysia, Singapore and Japan for the treatment of endometriosis. It is lowers the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation. Dienogest exhibits highly selective binding to the progesterone receptor. It has high progestational and significant antiandrogenic activity, but only moderate antigonadotrophic activity. The most common adverse reactions in clinical trials for Natazia are headache (including migraines), breast pain, menstrual disorders, nausea or vomiting, acne, mood changes and increased weight. — NCATS
Clinical trial activity
59 trials · 41 clinical orgs · 5 marketing orgs
Earliest trial started Jul 1, 2002 (NCT00335218)
Timeline
2000s
2010s
- May 6, 2010
Bayer — Earliest FDA Approval
- May 6, 2010
Bayer — NDA Organization
- May 6, 2010
Bayer — NDA Secondary Org
- Mar 18, 2016
Teva — Marketing Organization
- Mar 18, 2016
Dr. Reddy's Laboratories — Marketing Organization
- Mar 9, 2017
Watson Pharmaceuticals — Marketing Organization
- May 9, 2017
Allergan PLC (2015) — Marketing Organization
Indications
Approved for
Studied for
- Acne Vulgaris · Phase 3
- Adenomyosis · Phase 4
- Anorexia Nervosa · Phase 2
- Biological Availability · Phase 1
- Contraception · Phase 4
- Contraceptives, Oral · Phase 3
- Dysmenorrhea · Phase 4
- Endometrial Neoplasms · Phase 4
- Endometriosis · Phase 4
- Headache · Phase 3
- Healthy Volunteers · Phase 4
- Infertility · Phase 4
- Leiomyoma · Phase 4
- Libido · Phase 3
- Metrorrhagia · Phase 3
- Ovarian Reserve · Phase 4
- Ovulation Inhibition · Phase 2
- Pelvic Pain · Phase 3
- Pharmacokinetics · Phase 1
- Pharmacology, Clinical · Phase 1
- Postmenopause · Phase 4
- Pregnancy, Unplanned · Phase 2
- Premenstrual Syndrome · Phase 3
- Therapeutic Equivalency · Phase 1
- Uterine Diseases · Phase 4
Mechanism of action
- Unspecified targetOTHER
Unknown
Combination products
natazia
with estradiol
Approval history
- approvedMay 6, 2010
Chemistry & pharmacology
SMILES
C[C@]12CCC3=C4CCC(=O)C=C4CC[C@H]3[C@@H]1CC[C@@]2(O)CC#N- Mol. weight
- 311.418 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaDienogest ↗
- NCATS46M3EV8HHE ↗
- ChEMBLCHEMBL1201864 ↗
Also known as
- 17alpha-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
- 17alpha-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile
- 17 alpha-cyanomethyl-17 beta-hydroxy-13 beta-methylgona-4,9-dien-3-one
- 17-alpha-cyanomethyl-17-beta-hydroxy-estra-4,9(10)-dien-3-one
- 17-alpha-cyanomethyl-17-beta-hydroxy-estra-4,9(10)-dien-3-one
- 17 alpha-cyanomethyl-17 beta-hydroxyestra-4,9(10)-diene-3-one
- 19-norpregna-4,9-diene-21-nitrile, 17-hydroxy-3-oxo-, (17alpha)-
- bay 86-5258
- bay 86-5258
- dienogest
- dienogest
- dienogest
- dienogest
- dienogest
- dienogest
- dienogest
- dienogest
- dienogest
- dienogestril
- dienogestril
- dienogestril
- dienogestum
- dienogestum
- dinagest
- endometrion
- endometrion
- endometrion
- mjr-35
- mjr-35
- natazia
- natazia
- sts 557
- sts 557
- sts-557
- sts-557
- sts-557
- visanne
- visanne
- zk-37659
- zk-37659
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07164183 | Phase 3 | Sep 11, 2025 | Alcea |
| NCT06719934 | Phase 1 | Jan 1, 2025 | Al Azhar University |
| NCT06543550 | Phase 4 | Jul 30, 2024 | — |
| NCT06577974 | N/A | Jul 1, 2024 | Cairo University |
| NCT06396208 | N/A | May 1, 2024 | Chulalongkorn University |
| NCT06145438 | Phase 3 | Sep 4, 2023 | Diponegoro University |
| NCT06115408 | Phase 2/Phase 3 (Phase 3) | Jul 1, 2023 | Ain Shams University |
| NCT05697471 | Phase 3 | Feb 25, 2023 | Far Eastern Memorial Hospital |
| NCT06316206 | Phase 4 | Jan 1, 2023 | University of Palermo, University of Roma La Sapienza |
| NCT05332106 | Phase 1 | Mar 12, 2022 | Azidus, Grunenthal |
| NCT05476172 | N/A | Apr 1, 2021 | Uludag University |
| NCT05013242 | Phase 4 | Dec 25, 2020 | Mansoura University |
| NCT04230083 | Phase 1 | Dec 7, 2019 | Grunenthal |
| NCT04193852 | Phase 1 | Nov 9, 2019 | Grunenthal |
| NCT04374006 | Early Phase 1 (Phase 1) | Nov 1, 2019 | University of Indonesia |
| NCT03945513 | Phase 3 | Aug 31, 2019 | Exeltis, Insud Pharma |
| NCT03890042 | N/A | Mar 1, 2019 | Assiut University |
| NCT03789123 | Phase 4 | Jan 1, 2019 | Bagcilar Research and Training Hospital, Istanbul University, Kocaeli University, Suleymaniye Birth And Women's Health Education And Research Hospital |
| NCT03654144 | Phase 4 | Nov 30, 2018 | Assiut University |
| NCT04500743 | N/A | Aug 1, 2018 | National Research Center, Egypt |
Organizations
Research & Development (41)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 25 | 25 | 4 | 2002 |
| Grunenthal | For profit | 3 | 3 | 1 | 2019 |
| Ain Shams University | Academic/Hospital | 2 | 2 | 2 | 2014 |
| American University of Beirut | Academic/Hospital | 2 | 2 | 2 | 2017 |
| Assiut University | Academic/Hospital | 2 | 2 | 2 | 2018 |
| Cairo University | Academic/Hospital | 2 | 2 | 2 | 2015 |
| Adana Numune Training and Research Hospital | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Ajou University | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Al Azhar University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Alcea | For profit | 1 | 1 | 1 | 2025 |
| Azidus | For profit | 1 | 0 | 1 | 2022 |
| Bagcilar Research and Training Hospital | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Chulalongkorn University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Diponegoro University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Ewha Womans University | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Exeltis | For profit | 1 | 0 | 1 | 2019 |
| Far Eastern Memorial Hospital | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Fundación Santa Fe de Bogota | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Insud Pharma | For profit | 1 | 1 | 1 | 2019 |
| Istanbul University | Academic/Hospital | 1 | 0 | 1 | 2019 |
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Allergan PLC (2015) | For profit | MKTG | May 9, 2017 |
| Bayer | For profit | NDA | May 6, 2010 |
| Bayer | For profit | NDA2 | May 6, 2010 |
| Dr. Reddy's Laboratories | For profit | MKTG | Mar 18, 2016 |
| Teva | For profit | MKTG | Mar 18, 2016 |
| Watson Pharmaceuticals | For profit | MKTG | Mar 9, 2017 |