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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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fyremadel | ANDA | 2023-10-26 |
| ganirelix acetate | ANDA | 2023-12-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ovarian hyperstimulation syndrome | — | D016471 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| S0132 | Injection, ganirelix acetate, 250 mcg |
Clinical
Clinical Trials
99 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 | HP_0000789 | — | 1 | 3 | 9 | 15 | 13 | 39 |
| Fertilization in vitro | D005307 | — | — | — | 1 | 1 | 3 | 3 | 8 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | 1 | — | 1 | 1 | 6 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 1 | 1 | — | 1 | 2 | 4 |
| Ovulation induction | D010062 | — | — | 1 | 1 | — | 2 | 1 | 4 |
| Fertility | D005298 | — | — | 1 | — | — | 1 | 1 | 3 |
| Fertility preservation | D059247 | — | — | — | — | — | 1 | 1 | 2 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | — | 2 | — | 2 |
| Live birth | D050498 | — | — | — | — | — | 1 | — | 1 |
| Ovarian cysts | D010048 | HP_0000138 | N83.1 | — | — | — | 1 | — | 1 |
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 | 1 | — | 3 | 6 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | 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 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | — | — | — | 1 |
| Leiomyoma | D007889 | HP_0000131 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral arterial diseases | D002539 | EFO_1000859 | — | 1 | — | — | — | — | 1 |
| Precocious puberty | D011629 | — | E22.8 | 1 | — | — | — | — | 1 |
| Delayed puberty | D011628 | HP_0000823 | 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 |
| Embryo implantation | D010064 | — | — | — | — | — | — | 2 | 2 |
| Preimplantation diagnosis | D019836 | — | — | — | — | — | — | 1 | 1 |
| Assisted reproductive techniques | D027724 | — | — | — | — | — | — | 1 | 1 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 1 | 1 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 1 | 1 |
| Oocyte donation | D018587 | — | — | — | — | — | — | 1 | 1 |
| Vitrification | D058989 | — | — | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 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
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Ganirelix
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,571 adverse events reported
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