MedPath

Ganirelix

Generic Name
Ganirelix
Brand Names
Fyremadel, Orgalutran, Ganirelix Gedeon Richter
Drug Type
Small Molecule
Chemical Formula
C80H113ClN18O13
CAS Number
124904-93-4
Unique Ingredient Identifier
IX503L9WN0

Overview

Ganirelix is a synthetic decapeptide and a competitive gonadotropin-releasing hormone (GnRH) antagonist. Derived from endogenous GnRH, ganirelix has amino acid substitutions. Ganirelix is indicated for controlled ovarian hyperstimulation in assisted reproduction techniques. The first case of pregnancy achieved after the use of ganirelix in an assisted reproduction program was reported in 1998. Ganirelix was first approved by the FDA on July 29, 1999.

Background

Ganirelix is a synthetic decapeptide and a competitive gonadotropin-releasing hormone (GnRH) antagonist. Derived from endogenous GnRH, ganirelix has amino acid substitutions. Ganirelix is indicated for controlled ovarian hyperstimulation in assisted reproduction techniques. The first case of pregnancy achieved after the use of ganirelix in an assisted reproduction program was reported in 1998. Ganirelix was first approved by the FDA on July 29, 1999.

Indication

Ganirelix is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques (ART).

Associated Conditions

No associated conditions information available.

FDA Approved Products

Ganirelix Acetate
Manufacturer:Fresenius Kabi USA, LLC
Route:SUBCUTANEOUS
Strength:250 ug in 0.5 mL
Approved: 2023/02/01
NDC:65219-028
Ganirelix Acetate
Manufacturer:Amphastar Pharmaceuticals, Inc.
Route:SUBCUTANEOUS
Strength:250 ug in 0.5 mL
Approved: 2022/04/19
NDC:0548-5001
Ganirelix Acetate
Manufacturer:Lupin Pharmaceuticals, Inc.
Route:SUBCUTANEOUS
Strength:250 ug in 0.5 mL
Approved: 2024/02/20
NDC:70748-274
Ganirelix Acetate
Manufacturer:Organon LLC
Route:SUBCUTANEOUS
Strength:250 ug in 0.5 mL
Approved: 2024/02/16
NDC:78206-138
GANIRELIX ACETATE
Manufacturer:Gland Pharma Limited
Route:SUBCUTANEOUS
Strength:250 ug in 0.5 mL
Approved: 2023/11/29
NDC:68083-472

Singapore Approved Products

ORGALUTRAN SOLUTION FOR INJECTION 0.25 mg/0.5 ml
Manufacturer:VETTER PHARMA-FERTIGUNG GMBH & CO KG
Form:INJECTION
Strength:0.25 mg/0.5 ml
Online:Yes
Approved: 2003/01/07
Approval:SIN12165P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath