Ganirelix acetate, Orgalutran(ganirelix)
Fyremadel, Ganirelix, Orgalutran (ganirelix) is a protein pharmaceutical. Ganirelix was first approved as Ganirelix acetate on 1999-07-29. It is used to treat ovarian hyperstimulation syndrome in the USA. It has been approved in Europe to treat assisted reproductive techniques, female infertility, and ovulation induction.
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Commercial
Therapeutic Areas
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Fyremadel, Ganirelix
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fyremadel | ANDA | 2025-01-06 |
| ganirelix acetate | ANDA | 2026-05-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ovarian hyperstimulation syndrome | — | D016471 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| S0132 | Injection, ganirelix acetate, 250 mcg |
Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 1 | 4 | 10 | 17 | 21 | 51 |
| Fertilization in vitro | D005307 | — | — | — | 1 | 2 | 4 | 3 | 10 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | 1 | — | 1 | 1 | 6 |
| Ovulation induction | D010062 | — | — | 1 | 1 | — | 3 | 2 | 6 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 1 | 1 | — | 1 | 2 | 4 |
| Premature menopause | D008594 | — | E28.31 | 1 | 1 | — | 1 | 1 | 3 |
| Fertility | D005298 | — | — | 1 | — | — | 1 | 1 | 3 |
| Syndrome | D013577 | — | — | 1 | — | — | 1 | 1 | 3 |
| Preimplantation diagnosis | D019836 | — | — | — | — | — | 1 | 1 | 2 |
| Oocyte donation | D018587 | — | — | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | 2 | 2 | — | 4 | 8 |
| Fatigue | D005221 | — | R53.83 | — | — | 1 | — | — | 1 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | 1 | — | — | 1 |
| Ovarian reserve | D065851 | EFO_0004770 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Male breast neoplasms | D018567 | — | — | 1 | 1 | — | — | 1 | 2 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | 1 | — | — | 1 | 2 |
| Helping behavior | D006379 | — | — | 1 | 1 | — | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | — | — | — | 1 |
| Leiomyoma | D007889 | — | D25 | 1 | 1 | — | — | — | 1 |
| Ectopic pregnancy | D011271 | — | O00 | 1 | 1 | — | — | — | 1 |
| Salpingitis | D012488 | — | N70.91 | 1 | 1 | — | — | — | 1 |
| Fertilization | D005306 | — | — | — | 1 | — | — | — | 1 |
| Orthostatic intolerance | D054971 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep deprivation | D012892 | — | F51.12 | 2 | — | — | — | — | 2 |
| Precocious puberty | D011629 | — | E22.8 | 1 | — | — | — | — | 1 |
| Delayed puberty | D011628 | — | E30.0 | 1 | — | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 4 | 4 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 2 | 2 |
| Embryo implantation | D010064 | — | — | — | — | — | — | 2 | 2 |
| Assisted reproductive techniques | D027724 | — | — | — | — | — | — | 1 | 1 |
| Oogenesis | D009866 | — | — | — | — | — | — | 1 | 1 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 1 | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 1 | 1 |
| Vitrification | D058989 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ganirelix |
| INN | ganirelix |
| Description | Ganirelix acetate (or diacetate), sold under the brand names Orgalutran and Antagon among others, is an injectable competitive gonadotropin-releasing hormone antagonist (GnRH antagonist). It is primarily used in assisted reproduction to control ovulation. The drug works by blocking the action of GnRH upon the pituitary, thus rapidly suppressing the production and action of LH and FSH. Ganirelix is used in fertility treatment to prevent premature ovulation that could result in the harvesting of eggs that are too immature to be used in procedures such as in vitro fertilization.
|
| Classification | Protein |
| Drug class | hormone-release inhibiting peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC/N=C(\NCC)NCCCC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CCCCN/C(=N/CC)NCC)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@@H](Cc1cccnc1)NC(=O)[C@@H](Cc1ccc(Cl)cc1)NC(=O)[C@@H](Cc1ccc2ccccc2c1)NC(C)=O)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 124904-93-4 |
| RxCUI | 259264 |
| ChEMBL ID | CHEMBL1251 |
| ChEBI ID | — |
| PubChem CID | 16186319 |
| DrugBank | DB06785 |
| UNII ID | IX503L9WN0 (ChemIDplus, GSRS) |
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Financial
Estimated US medical usage
Ganirelix
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Safety
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Adverse Events
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2,230 adverse events reported
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