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Oral Dienogest
Dienogest is a synthetic progestin that suppresses ovulation and alters the endometrium to treat endometriosis.
Dienogest is a synthetic progestin that suppresses ovulation and alters the endometrium to treat endometriosis. Used for Endometriosis pain management.
At a glance
| Generic name | Oral Dienogest |
|---|---|
| Sponsor | Bio Meds Pharmaceutica Ltda |
| Drug class | Progestin |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Gynecology |
| Phase | FDA-approved |
Mechanism of action
Dienogest acts as a selective progestin receptor agonist with high affinity for progesterone receptors, particularly in endometrial tissue. It inhibits the hypothalamic-pituitary-ovarian axis to suppress ovulation and causes decidualization and atrophy of ectopic endometrial lesions. This dual action reduces both the proliferation of endometrial tissue outside the uterus and associated pain symptoms.
Approved indications
- Endometriosis pain management
Common side effects
- Headache
- Breast pain/tenderness
- Irregular bleeding/amenorrhea
- Nausea
- Mood changes/depression
- Weight gain
Key clinical trials
- Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis
- Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis (PHASE3)
- Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma (PHASE2, PHASE3)
- Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery (PHASE3)
- Ttt of Adenomyosis (PHASE1)
- To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada) (PHASE3)
- Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis (PHASE4)
- Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oral Dienogest CI brief — competitive landscape report
- Oral Dienogest updates RSS · CI watch RSS
- Bio Meds Pharmaceutica Ltda portfolio CI