NIKKI (drospirenone)
Nikki is a combination oral contraceptive containing drospirenone, a progestin, and ethinyl estradiol, an estrogen. It is indicated for use by females of reproductive potential to prevent pregnancy and to treat symptoms of premenstrual dysphoric disorder (PMDD). Additionally, the medication is approved for the treatment of moderate acne in patients at least 14 years of age. For both PMDD and acne indications, the drug is intended for patients who also desire an oral contraceptive for birth control.
How NIKKI Works
Nikki is a combination oral contraceptive (COC) that utilizes two active hormonal components, drospirenone and ethinyl estradiol. The primary therapeutic effect is achieved by lowering the risk of pregnancy through the suppression of ovulation. By providing a combination of a progestin and an estrogen, the medication interferes with the hormonal cycles necessary for reproductive processes.
Details
- Status
- Prescription
- First Approved
- 2014-05-27
- Routes
- ORAL
- Dosage Forms
- TABLET
NIKKI Approval History
What NIKKI Treats
2 indicationsNIKKI is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Premenstrual Dysphoric Disorder
- Acne
NIKKI Boxed 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 Nikki ( 4 ). Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) 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 wit...
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 Nikki ( 4 ). Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 ) 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) ] .
NIKKI 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.
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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.
NIKKI FDA Label Details
Indications & Usage
NIKKI is indicated for the treatment of Premenstrual Dysphoric Disorder; Acne.
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 Nikki ( 4 ). Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.