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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Fyremadel, Ganirelix
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fyremadel | ANDA | 2023-10-26 |
| ganirelix acetate | ANDA | 2024-10-25 |
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
102 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | HP_0000789 | — | 1 | 4 | 11 | 18 | 19 | 51 |
| Fertilization in vitro | D005307 | — | — | — | 1 | 1 | 5 | 3 | 10 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | 2 | 1 | 1 | 3 | 7 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | 1 | — | 1 | 1 | 6 |
| Ovulation induction | D010062 | — | — | 1 | 1 | — | 3 | 1 | 5 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 1 | 1 | — | 1 | 2 | 4 |
| Premature menopause | D008594 | HP_0008209 | E28.31 | 1 | 1 | — | 1 | 2 | 4 |
| Syndrome | D013577 | — | — | 2 | — | — | 1 | 1 | 4 |
| Fertility | D005298 | — | — | 1 | — | — | 1 | 1 | 3 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | 1 | 2 | — | 3 |
Show 11 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | 1 | — | — | 1 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | 1 | 2 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Sleep deprivation | D012892 | — | F51.12 | 2 | — | — | — | — | 2 |
| 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 |
| Assisted reproductive techniques | D027724 | — | — | — | — | — | — | 1 | 1 |
| Oogenesis | D009866 | — | — | — | — | — | — | 1 | 1 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 1 | 1 |
| Vitrification | D058989 | — | — | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
No data
Variants
No data
Financial
Estimated US medical usage
Ganirelix
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
1,927 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use