goserelin
Trade name: zoladex
Small moleculeapproved
Approved
Dec 29, 1989
Goserelin is a synthetic decapeptide analogue of LHRH. Goserelin acts as a potent inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation. The result is sustained suppression of LH and serum testosterone levels. Goserelin is used to treat hormone-sensitive cancers of the breast (in pre- and peri- menopausal women) and prostate, and some benign gynaecological disorders (endometriosis, uterine fibroids and endometrial thinning). In addition, goserelin is used in assisted reproduction and in the treatment of precocious puberty. Goserelin is marketed under the brand names Zoladex, by AstraZeneca, or goserelin acetate. — NCATS
Clinical trial activity
289 trials · 251 clinical orgs · 1 marketing orgs
Phase 1
35
Phase 2
220
Phase 3
101
Phase 4
19
Earliest trial started May 1, 1987 (NCT00849082)
Timeline
1980s
- Jan 1, 1987
Earliest Phase 3 Sponsor(trial)
- Dec 29, 1989
Tersera Theraps Llc — Earliest FDA Approval
- Dec 29, 1989
Tersera Theraps Llc — Marketing Organization
- Dec 29, 1989
Tersera Theraps Llc — NDA Organization
- Dec 29, 1989
Tersera Theraps Llc — NDA Secondary Org
Indications
Studied for
- Androgens · Phase 3
- Anemia · Phase 3
- Azoospermia · Phase 2
- Breast Diseases · Phase 2/Phase 3
- Breast Neoplasms · Phase 4
- Breast Neoplasms, Male · Phase 3
- Bulbo-Spinal Atrophy, X-Linked · Phase 4
- Carcinoma · Phase 2
- Cardiovascular Diseases · Phase 4
- Castration · Phase 3
- Drug Evaluation · Phase 2/Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Drug Therapy · Phase 2/Phase 3
- Endometriosis · Phase 4
- Fallopian Tube Neoplasms · Phase 2
- Hamartoma · Phase 2
- Hot Flashes · Phase 3
- Hypogonadism · Phase 4
- Infertility · Phase 4
- Inflammatory Breast Neoplasms · Phase 2/Phase 3
- Intestinal Neoplasms · Phase 3
- Leiomyoma · Phase 4
- Liver Diseases · Phase 4
- Menopause · Phase 3
- Metabolic Syndrome · Phase 2
- Muscle Hypotonia · Phase 3
- Muscular Atrophy · Phase 3
- Musculoskeletal Diseases · Phase 4
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 4
- Osteoporosis · Phase 3
- Ovarian Diseases · Phase 3
- Ovarian Neoplasms · Phase 2
- Primary Ovarian Insufficiency · Phase 2
- Prostatic Neoplasms · Phase 4
- Prostatic Neoplasms, Castration-Resistant · Phase 3
- Recurrence · Phase 3
- Salivary Gland Neoplasms · Phase 2
- Salvage Therapy · Phase 3
- Sarcopenia · Phase 3
- Sexual Dysfunction, Physiological · Phase 3
- Therapeutic Equivalency · Phase 1
- Triple Negative Breast Neoplasms · Phase 2
- Urination Disorders · Phase 3
Mechanism of action
GNRHR agonist
Approval history
- approvedDec 29, 1989
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)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)NNC(N)=O- Mol. weight
- 1269.43 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL1201247 ↗
- WikipediaGoserelin ↗
- NCATS0F65R8P09N ↗
- ChEMBLCHEMBL1200501 ↗
Also known as
- decapeptide i
- goserelin
- goserelin
- goserelin
- goserelin
- goserelin
- goserelin
- goserelin
- goserelin
- goserelin
- goserelin
- goserelin acetate
- goserelin acetate
- goserelin acetate
- goserelin acetate
- goserelin acetate
- ici-118630
- ici-118630
- novgos
- zoladex
- zoladex
- zoladex
- zoladex
- zoladex
- zoladex la
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07310420 | Phase 1 | Dec 29, 2025 | Tersera Theraps Llc |
| NCT07158021 | Phase 2 | Dec 1, 2025 | University of Michigan |
| NCT07179939 | Phase 2 | Sep 10, 2025 | Fudan University, Hengrui Therapeutics, Inc., People's Liberation Army of China |
| NCT07097259 | Phase 1 | Jul 21, 2025 | Merck KGaA, Merck Serono |
| NCT06953882 | Phase 2 | Jul 9, 2025 | Breast Cancer Research Foundation, Novartis, Yale University |
| NCT06997887 | N/A | May 9, 2025 | National Taiwan University |
| NCT06636591 | N/A | Nov 18, 2024 | Fudan University |
| NCT06523530 | Phase 4 | Oct 31, 2024 | Aristotle University of Thessaloniki, Government of Greece, Hellenic Army |
| NCT06582004 | N/A | Sep 30, 2024 | National Taiwan University |
| NCT06582446 | Phase 2 | Sep 16, 2024 | German Oncology Center, Cyprus |
| NCT06455969 | Phase 4 | Jul 15, 2024 | United States Army, University of Pittsburgh |
| NCT06348134 | Phase 2 | Jul 1, 2024 | University of Chicago |
| NCT06378866 | Phase 2 | Jun 3, 2024 | Mayo Clinic |
| NCT06385847 | Phase 2 | May 31, 2024 | Xiamen University |
| NCT06575257 | Phase 2 | May 1, 2024 | Xijing Hospital |
| NCT06387056 | Phase 2 | Apr 1, 2024 | Xiamen University |
| NCT06225284 | Phase 2 | Feb 15, 2024 | Debiopharm, National Taiwan University |
| NCT05827081 | Phase 3 | Jan 16, 2024 | Novartis |
| NCT06282588 | Phase 2/Phase 3 (Phase 3) | Dec 13, 2023 | Bayer, Cancer Research Antwerp, University of Antwerp, Veracyte, Inc. |
| NCT05870579 | Phase 1 | Nov 13, 2023 | Novartis |
Showing 20 of 289 trials
Page 1 / 15
Organizations
Research & Development (251)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 63 | 19 | 3 | 1994 |
| AstraZeneca | For profit | 18 | 9 | 4 | 2000 |
| Novartis | For profit | 15 | 10 | 4 | 2003 |
| Harvard University | Academic/Hospital | 14 | 6 | 4 | 1995 |
| University of Texas at Houston | Academic/Hospital | 13 | 9 | 3 | 2003 |
| Southwest Oncology Group | Academic/Hospital | 12 | 7 | 2 | 1995 |
| Fudan University | Academic/Hospital | 11 | 9 | 3 | 2008 |
| Pfizer | For profit | 9 | 0 | 3 | 2006 |
| NRG Oncology | Academic/Hospital | 8 | 3 | 2 | 2005 |
| Radiation Therapy Oncology Group | Academic/Hospital | 8 | 8 | 2 | 1994 |
| University of Washington | Academic/Hospital | 8 | 5 | 2 | 1999 |
| Washington University in St. Louis | Academic/Hospital | 8 | 6 | 3 | 2005 |
| Eastern Cooperative Oncology Group | Academic/Hospital | 7 | 2 | 2 | 1995 |
| Ferring | For profit | 7 | 6 | 2 | 2009 |
| Jiao Tong University | Academic/Hospital | 7 | 6 | 3 | 2014 |
| Mayo Clinic | Academic/Hospital | 6 | 4 | 1 | 2002 |
| Vanderbilt University | Academic/Hospital | 6 | 4 | 2 | 2009 |
| Canadian Cancer Trials Group | Academic/Hospital | 5 | 3 | 1 | 1995 |
| Cornell University | Academic/Hospital | 5 | 3 | 2 | 1998 |
| Janssen Pharmaceutica NV | For profit | 5 | 0 | 2 | 2013 |
251 organizations
Page 1 / 13
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Tersera Theraps Llc | For profit | MKTG | Dec 29, 1989 |
| Tersera Theraps Llc | For profit | NDA | Dec 29, 1989 |
| Tersera Theraps Llc | For profit | NDA2 | Dec 29, 1989 |