BEYAZ (drospirenone)
Beyaz is a combination oral contraceptive containing drospirenone, ethinyl estradiol, and a folate. It is indicated for use by females of reproductive potential to prevent pregnancy and to increase folate levels. The medication is also approved to treat moderate acne in patients at least 14 years old and to manage symptoms of premenstrual dysphoric disorder (PMDD) in those who choose to use an oral contraceptive for birth control.
How BEYAZ Works
Beyaz is a combined oral contraceptive that utilizes a progestin and an estrogen to prevent pregnancy. The medication functions primarily by suppressing ovulation, which is the biological process of releasing an egg from the ovary. By inhibiting this process, the drug effectively lowers the risk of conception in females of reproductive potential.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-09-24
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
BEYAZ Approval History
What BEYAZ Treats
2 indicationsBEYAZ is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Premenstrual Dysphoric Disorder
- Acne
BEYAZ 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 Beyaz. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
BEYAZ 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 BEYAZ
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT06345560 | 077766 | Ph 1, Ph 2 | recruiting | Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study |
| NCT07293728 | STUDY00028768 | Ph 4 | not yet recruiting | A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia |
| NCT05461573 | CF113-303 | Ph 3 | completed | Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females |
| NCT05706753 | CR109284 2022-002828-12, 70033093THR1009 | Ph 1 | completed | A Study of Milvexian in Healthy Adult Females |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
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.
BEYAZ FDA Label Details
Indications & Usage
FDA Label (PDF)BEYAZ is indicated for the treatment of Premenstrual Dysphoric Disorder; Acne.
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...
BEYAZ Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for BEYAZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 5 active patents
Trial Analysis
- • 6 total trials
- • Stage: Stable
Competitive Landscape
- • 17 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment