Hormonal & Sexual Health

Ganirelix

Last updated 12 August 2026

Evidence on fileFDA-approved · 1 randomised human trial · 1 citation not yet graded

Strongest sourceA double-blind, randomized, dose-finding study to assess the efficacy of the gonadotrophin-releasing hormone… (randomised human trial)

Regulatory status

Approved by the FDA. Marketed as GANIRELIX ACETATE, FYREMADEL. Earliest approval 1999-07-29. Application NDA021057, ANDA204246, ANDA212613, ANDA214996, ANDA215658, ANDA216075, ANDA218855.

An approval grades as rung 1 on this site, because 21 CFR 314.126 requires adequate and well-controlled human investigations and one cannot be granted without them. It covers specific indications and doses, though, and does not transfer to other uses of the same molecule.

Dosing on file unverified

250 mcg SC QD during mid-late follicular phase until hCG day

Carried from a source that labels it unverified, and reproduced with that label attached. A record of what is reported, not a recommendation. No citation on this page establishes it.

Literature on file 3

human RCT
A double-blind, randomized, dose-finding study to assess the efficacy of the gonadotrophin-releasing hormone antagonist ganirelix... [title truncated in API summary] (Human Reproduction 1998, cited 279x) graded on: a randomised study — “randomized, dose-finding study”
human RCT
FDA approval NDA021057, ANDA204246, ANDA212613, ANDA214996, ANDA215658, ANDA216075, ANDA218855 graded on: an FDA approval (NDA021057, ANDA204246, ANDA212613, ANDA214996, ANDA215658, ANDA216075, ANDA218855), which requires adequate and well-controlled human investigations — “NDA021057, ANDA204246, ANDA212613, ANDA214996, ANDA215658, ANDA216075, ANDA218855”

Not graded

1 citation whose study design could not be read from the title. Left ungraded rather than guessed at.

not graded
Treatment with the gonadotrophin-releasing hormone antagonist ganirelix in women undergoing ovarian stimulation... [title truncated in API summary] (Human Reproduction 2000, cited 291x)

Identity

Space-filling 3D model of Ganirelix, carbon grey, nitrogen blue, oxygen red — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

2D chemical structure of Ganirelix — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

Molecular weight: 1570.3
Molecular formula: C80H113ClN18O13
CAS number: 124904-93-4
PubChem CID: 16130957
InChI key: GJNXBNATEDXMAK-PFLSVRRQSA-N
Sequence: XXXSYXLXPA
SMILES: CCNC(=NCCCC[C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN=C(NCC)NCC)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(=O)N)NC(=O)[C@H](CC2=CC=C(C=C2)O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC3=CN=CC=C3)NC(=O)[C@@H](CC4=CC=C(C=C4)Cl)NC(=O)[C@@H](CC5=CC6=CC=CC=C6C=C5)NC(=O)C)NCC
InChI: InChI=1S/C80H113ClN18O13/c1-9-84-79(85-10-2)88-38-17-15-24-60(70(104)94-62(41-49(5)6)71(105)93-61(25-16-18-39-89-80(86-11-3)87-12-4)78(112)99-40-20-26-68(99)77(111)90-50(7)69(82)103)92-73(107)64(44-53-30-35-59(102)36-31-53)97-76(110)67(48-100)98-75(109)66(46-55-21-19-37-83-47-55)96-74(108)65(43-52-28-33-58(81)34-29-52)95-72(106)63(91-51(8)101)45-54-27-32-56-22-13-14-23-57(56)42-54/h13-14,19,21-23,27-37,42,47,49-50,60-68,100,102H,9-12,15-18,20,24-26,38-41,43-46,48H2,1-8H3,(H2,82,103)(H,90,111)(H,91,101)(H,92,107)(H,93,105)(H,94,104)(H,95,106)(H,96,108)(H,97,110)(H,98,109)(H2,84,85,88)(H2,86,87,89)/t50-,60-,61+,62+,63-,64+,65-,66-,67+,68+/m1/s1

Notes unverified prose

FDA-approved (Ganirelix Acetate); DailyMed; Drugs.com; FDA-approved

Not on file 0

All 8 tracked fields hold a value on this record: molecular weight and formula, CAS number, PubChem CID, amino-acid sequence, SMILES, InChI and InChI key.

Counted from the record itself, not from what a source said it was missing. 136 of 185 records still have at least one empty.