Elinzanetant
LYNKUET
What it isDual NK1 and NK3 receptor antagonist; menopausal vasomotor symptoms.
Why this oneBlocking both neurokinin pathways targets hot flashes and associated sleep disruption without hormones.
What limits itCheck liver tests; transaminase elevation can end treatment, while somnolence and dizziness make driving unsafe.
FDA-approved for
- menopausal vasomotor symptoms (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Moderate to severe vasomotor symptoms due to menopause | Adults | 120 mg QHS | 120 mg QHS | 120 mg QHS |
Renal End-stage renal disease (with or without hemodialysis): not recommended
Hepatic Moderate to severe hepatic impairment: not recommended; do not start if ALT/AST ≥2×ULN or total bilirubin ≥2×ULN
Instructions
- Take 120 mg (two 60 mg capsules) at bedtime, about the same time each day, with water; with or without food.
- Swallow capsules whole; do not cut, crush, or chew.
- Obtain baseline hepatic labs; do not start if transaminases or bilirubin ≥2×ULN; recheck at 3 months.
- If a dose is missed, take the next dose as scheduled; do not double.
Contraindications
- Pregnancy — may cause pregnancy loss or stillbirth
Cautions
- CNS depressant effect and daytime impairment (somnolence)
- Hepatic transaminase elevations
- Risk of pregnancy loss or stillbirth
- Risk of seizure
Adverse reactions
- Headache
- Fatigue
- Dizziness
- Somnolence
Pregnancy Contraindicated; may cause pregnancy loss or stillbirth.
Lactation No human data; elinzanetant present in animal milk.
NO BOXED WARNINGS
Principal riskTransaminase rise
Cost, est. cash$500–$800/month
Generic entry2039 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Elinzanetant ballicule
