nafarelin
Trade name: synarel
Approved
Feb 13, 1990
Nafarelin acetate (brand name Synarel) is a synthetic agonist of gonadotrophin-releasing hormone (GnRH) [luteinising hormone-releasing hormone (LH-RH), which is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions and for the treatment of central precocious puberty (CPP). Nafarelin has also been used effectively in in vitro fertilisation programmes, and in hirsute women and those with uterine leiomyoma, particularly to induce preoperative fibroid shrinkage. Side effects are related to the low estrogen state and include hot flashes, vaginal dryness, headaches, mood changes, and decreased interest in sex. — NCATS
Clinical trial activity
8 trials · 10 clinical orgs · 2 marketing orgs
Earliest trial started Sep 1, 2002 (NCT00034047)
Timeline
1980s
- Jul 20, 1988
Orphan Drug Designation
1990s
- Feb 13, 1990
G D Searle — Earliest FDA Approval
- Feb 13, 1990
G D Searle — NDA Secondary Org
- Feb 13, 1990
G D Searle — NDA Organization
- Feb 13, 1990
Pfizer — Marketing Organization
- Feb 13, 1990
Pfizer — NDA Secondary Org
2000s
- Jan 1, 2002
Earliest Phase 1 Sponsor(trial)
Indications
Studied for
- Abortion, Spontaneous · Phase 4
- Embryo Transfer · Early Phase 1
- Endometriosis · Phase 1/Phase 2
- Fertilization in Vitro · Phase 3
- Infertility · Phase 4
- Live Birth · Phase 4
- Ovarian Hyperstimulation Syndrome · Phase 4
- Pelvic Pain · Phase 1/Phase 2
- Pregnancy Complications · Phase 4
- Quality of Life · Phase 4
- Spermatozoa · Phase 3
Mechanism of action
GNRHR agonist
Approval history
- approvedFeb 13, 1990
Chemistry & pharmacology
SMILES
CC(C)C[C@H](NC(=O)[C@@H](Cc1cccc2ccccc12)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O- Mol. weight
- 1322.5 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL1201309 ↗
- WikipediaNafarelin ↗
- NCATS1X0094V6JV ↗
- ChEMBLCHEMBL1200671 ↗
Also known as
- nafarelin
- nafarelin
- nafarelin
- nafarelin
- nafarelin
- nafarelin
- nafarelin
- nafarelin
- nafarelin
- nafarelin
- nafarelina
- nafarelina
- nafarelin acetate
- nafarelin acetate
- nafarelin acetate
- nafarelin acetate
- nafareline
- nafaréline
- nafaréline
- nafarelinum
- nafarelinum
- rs-94991-298
- rs-94991-298
- synarel
- synarel
- synarel
- synarel
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06870266 | Early Phase 1 (Phase 1) | Mar 31, 2025 | Hebrew University |
| NCT06150703 | Phase 3 | Feb 29, 2024 | Assistance Publique - Hôpitaux de Paris |
| NCT04850261 | Phase 2 | May 1, 2021 | University of Bern |
| NCT04797338 | Phase 4 | Dec 29, 2017 | Hebrew University, Tel Aviv University |
| NCT02865681 | N/A | Jul 1, 2016 | New Hope Fertility Center |
| NCT00843570 | Phase 4 | Nov 1, 2009 | University of Oxford |
| NCT00756028 | Phase 4 | Jan 1, 2009 | University of Copenhagen |
| NCT00034047 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2002 | National Center for Complementary and Integrative Health (NCCIH), Oregon College of Oriental Medicine, Oregon Health and Science University |
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Hebrew University | Academic/Hospital | 2 | 2 | 2 | 2017 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 1 | 1 | 1 | 2024 |
| National Center for Complementary and Integrative Health (NCCIH) | Government | 1 | 1 | 1 | 2002 |
| New Hope Fertility Center | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Oregon College of Oriental Medicine | Academic/Hospital | 1 | 0 | 1 | 2002 |
| Oregon Health and Science University | Academic/Hospital | 1 | 0 | 1 | 2002 |
| Tel Aviv University | Academic/Hospital | 1 | 0 | 1 | 2017 |
| University of Bern | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2009 |
| University of Oxford | Academic/Hospital | 1 | 1 | 1 | 2009 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| G D Searle | For profit | NDA2 | Feb 13, 1990 |
| G D Searle | For profit | NDA | Feb 13, 1990 |
| Pfizer | For profit | MKTG | Feb 13, 1990 |
| Pfizer | For profit | NDA2 | Feb 13, 1990 |