NATAZIA (dienogest)
Natazia is a combination of a progestin and an estrogen used by women of reproductive age to prevent pregnancy. It also helps patients with heavy menstrual bleeding who do not have underlying organic pathology and prefer to use an oral contraceptive. While it serves these dual purposes, its effectiveness has not been studied in women with a body mass index greater than 30.
How NATAZIA Works
This medication works by lowering the risk of becoming pregnant. It achieves this therapeutic effect primarily by suppressing ovulation.
Details
- Status
- Prescription
- First Approved
- 2010-05-06
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
NATAZIA Approval History
What NATAZIA Treats
1 indicationsNATAZIA is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heavy Menstrual Bleeding
NATAZIA Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications ( 4 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications ( 4 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use Natazia. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
NATAZIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NATAZIA
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07164183 Baikal | IND-III-2024 | Ph 3 | recruiting | Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis |
| NCT06145438 ENDOSafe | 00000088 | Ph 3 | completed | Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery |
| NCT02352090 SYLVI results posted | SYLVI030785 | Ph 4 | completed | Synthetic vs Natural Estrogen in Combined Oral Contraception |
| NCT01738724 | FMRPUSP-UROGIN-002 | Ph 4 | terminated | Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin |
| NCT02728245 DOROSY | SNUBH_GO_052 | Ph 2 | withdrawn | Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma |
| NCT02599077 | FSantafeBogota | Ph 2, Ph 3 | suspended | Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas |
| NCT01697111 | 15457 | Ph 3 | completed | Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NATAZIA FDA Label Details
Indications & Usage
FDA Label (PDF)NATAZIA is indicated for the treatment of Heavy Menstrual Bleeding.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For t...
Pro Intelligence Preview
Deep insights for NATAZIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.