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Nextstellis (ESTETROL)
Nextstellis works by binding to estrogen receptors in the body, mimicking the effects of natural estrogen.
At a glance
| Generic name | ESTETROL |
|---|---|
| Sponsor | Mayne Pharma |
| Drug class | Estrogen |
| Target | Estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
Think of estrogen like a key that unlocks certain processes in the body. Nextstellis is a small molecule that acts like that key, allowing it to interact with estrogen receptors and influence various bodily functions, such as reproductive health and development.
Approved indications
- Prevent pregnancy
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NEXTSTELLIS, are contraindicated in females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.1) ] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning . Females over 35 years old who smoke should not use NEXTSTELLIS ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
Common side effects
- Any adverse reaction
- Mood disturbance
- Bleeding irregularities
- Headache
- Breast symptoms
- Dysmenorrhea
- Acne
- Weight increased
- Libido decreased
- Depression
- Migraine with aura (new onset)
- Severe migraine
Serious adverse events
- Thromboembolic event
- Venous thromboembolism
- Arterial thromboembolism
- Hyperkalemia
- Liver disease
Key clinical trials
- Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II) (PHASE3)
- Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women (PHASE2)
- International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
- International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
- Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study
- Single and Multiple Intravenous Administrations of Estetrol (E4) in Healthy Adult Volunteers (PHASE1)
- "Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition (NA)
- Estetrol/Drospirenone to Reduce the Average Size of Endometriomas (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nextstellis CI brief — competitive landscape report
- Nextstellis updates RSS · CI watch RSS
- Mayne Pharma portfolio CI