Ganirelix - PharmaKB

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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Therapeutic Areas

Therapeutic Area	MeSH
urogenital diseases	D000091642
endocrine system diseases	D004700
therapeutics	D013812
investigative techniques	D008919

Trade Name

FDA

EMA

Fyremadel, Ganirelix

Drug Products

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EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ganirelix acetate

Tradename	Company	Number	Date	Products
GANIRELIX ACETATE	Organon	N-021057 RX	1999-07-29	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
fyremadel	ANDA	2025-01-06
ganirelix acetate	ANDA	2024-10-25

Indications

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EMA

Indication	Ontology	MeSH	ICD-10
ovarian hyperstimulation syndrome	—	D016471	—

Agency Specific

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EMA

No data

Patent Expiration

No data

ATC Codes

H: Systemic hormonal preparations, excl. sex hormones and insulins

— H01: Pituitary and hypothalamic hormones and analogues

— H01C: Hypothalamic hormones

— H01CC: Anti-gonadotropin-releasing hormones

— H01CC01: Ganirelix

HCPCS

Code	Description
S0132	Injection, ganirelix acetate, 250 mcg

Clinical

No data

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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Orgalutran – Organon

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Ganirelix – Organon

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Estimated US medical usage

Ganirelix

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Safety

Black-box Warning

No Black-box warning

Adverse Events

0 adverse events reported