GEMMILY (ethinyl estradiol) · XIROMED
Gemmily is a combined oral contraceptive used by women of reproductive age to prevent pregnancy. It helps patients manage their reproductive health by providing a daily hormonal method of birth control. While it is used for a wide range of females, its effectiveness has not been studied in individuals with a body mass index greater than 35.
How GEMMILY Works
This medication works primarily by suppressing ovulation to lower the risk of pregnancy. It also creates changes in the cervical mucus to inhibit sperm penetration and modifies the lining of the uterus to reduce the likelihood of an egg implanting.
Details
- Status
- Prescription
- First Approved
- 2020-11-09
- Routes
- ORAL
- Dosage Forms
- CAPSULE
GEMMILY Approval History
What GEMMILY Treats
1 indicationsGEMMILY is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
GEMMILY Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 f...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 Gemmily. ( 4 ) ● Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
GEMMILY 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 GEMMILY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | 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 |
| 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.
GEMMILY FDA Label Details
Indications & Usage
1 INDICATION S AND USAGE Gemmily is indicated for use by females of reproductive age to prevent pregnancy [ see Clinical Studies ] . The efficacy of Gemmily in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. Gemmily i s an estrogen/progestin COC indicated for use by women to prevent pregnancy The efficacy of Gemmily in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For th...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.