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Norethisterone enantate
Norethisterone enantate is a Progestin; hormonal contraceptive Small molecule drug developed by London School of Hygiene and Tropical Medicine. It is currently FDA-approved for Contraception (long-acting injectable). Also known as: Noristerat.
Norethisterone enantate is a synthetic progestin that suppresses ovulation and alters the endometrium and cervical mucus to prevent pregnancy.
Norethisterone enantate is a small molecule used as a form of hormonal birth control to prevent pregnancy in women. It is administered via injection and may be used following childbirth, miscarriage, or abortion.
At a glance
| Generic name | Norethisterone enantate |
|---|---|
| Also known as | Noristerat |
| Sponsor | London School of Hygiene and Tropical Medicine |
| Drug class | Progestin; hormonal contraceptive |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception; Reproductive Health |
| Phase | FDA-approved |
Mechanism of action
As a long-acting progestin ester, norethisterone enantate works primarily by inhibiting the luteinizing hormone (LH) surge needed for ovulation. It also thickens cervical mucus to impede sperm penetration and alters the uterine lining to prevent implantation. The enantate ester formulation provides sustained release, allowing for extended contraceptive coverage with infrequent dosing.
Approved indications
- Contraception (long-acting injectable)
Common side effects
- Menstrual irregularities (amenorrhea, breakthrough bleeding)
- Headache
- Breast tenderness
- Weight changes
- Mood changes
Key clinical trials
- PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic.
- Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use. (NA)
- HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
- The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis (PHASE4)
- A Study to Evaluate the Acceptability and Preference for Contraceptive Options as Proxy for HIV Prevention Methods (NA)
- Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Norethisterone enantate CI brief — competitive landscape report
- Norethisterone enantate updates RSS · CI watch RSS
- London School of Hygiene and Tropical Medicine portfolio CI
Frequently asked questions about Norethisterone enantate
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Related
- Drug class: All Progestin; hormonal contraceptive drugs
- Target: All drugs targeting Progesterone receptor
- Manufacturer: London School of Hygiene and Tropical Medicine — full pipeline
- Therapeutic area: All drugs in Contraception; Reproductive Health
- Indication: Drugs for Contraception (long-acting injectable)
- Also known as: Noristerat
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing