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Synarel (NAFARELIN)
Synarel (generic name: NAFARELIN) is a Gonadotropin Releasing Hormone Receptor Agonist Recombinant protein drug developed by Pfizer. It is currently FDA-approved (first approved 1990) for Central Precocious Puberty, Endometriosis.
NAFARELIN (Synarel), marketed by Pfizer, is a gonadotropin-releasing hormone agonist primarily indicated for the treatment of central precocious puberty. Its key strength lies in its mechanism of action, which effectively reduces the production of sex hormones, making it a targeted therapy for its primary indication. The primary risk is the expiration of its key composition patent in 2028, which could lead to increased competition from generics and other alternatives such as Norethindrone, Lupron Depot, Provera, Zoladex, and Medroxyprogesterone.
At a glance
| Generic name | NAFARELIN |
|---|---|
| Sponsor | Pfizer |
| Drug class | Gonadotropin Releasing Hormone Receptor Agonist |
| Target | Gonadotropin-releasing hormone receptor |
| Modality | Recombinant protein |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1990 |
Approved indications
- Central Precocious Puberty
- Endometriosis
Common side effects
- acne
- transient breast enlargement
- vaginal bleeding
- emotional lability
- transient increase in pubic hair
- body odor
- seborrhea
- white or brownish vaginal discharge
- rhinitis
- hot flashes
- adrenal rest tumors
- pituitary apoplexy
Drug interactions
- Not specified
Key clinical trials
- Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles (PHASE3)
- Comparison of Pregnancy Rates in Modified Natural Frozen Embryo Transfer (FET) Cycle After Luteal Support with GnRH Agonist Versus Progesterone (EARLY_PHASE1)
- Intranasal Nafarelin For Triggering Oocyte Maturation (PHASE4)
- Injection Free IVF (PHASE2)
- Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study
- GnRH Agonist for Luteal Phase Support. (NA)
- Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders (PHASE4)
- Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization (NA)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Synarel CI brief — competitive landscape report
- Synarel updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Synarel
What is Synarel?
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Related
- Drug class: All Gonadotropin Releasing Hormone Receptor Agonist drugs
- Target: All drugs targeting Gonadotropin-releasing hormone receptor
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Central Precocious Puberty
- Indication: Drugs for Endometriosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing