Ganirelix acetate, Orgalutran(ganirelix acetate)
Orgalutran (ganirelix acetate) is a protein pharmaceutical. Ganirelix acetate 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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
| therapeutics | D013812 |
| investigative techniques | D008919 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
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 | 2022-03-03 |
| ganirelix acetate | ANDA | 2023-03-14 |
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
50 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 | EFO_0000545 | — | 1 | 6 | 9 | 5 | 21 | |
| Fertilization in vitro | D005307 | — | 1 | 1 | 1 | 3 | 6 | ||
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | — | 1 | 1 | 2 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | — | — | 1 | — | 2 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
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 |
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 | ||
| Fertility preservation | D059247 | — | — | — | — | 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 |
| Hyponatremia | D007010 | HP_0002902 | E87.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GANIRELIX ACETATE |
| 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 | 35825 |
| ChEMBL ID | CHEMBL1251 |
| ChEBI ID | — |
| PubChem CID | 16186319 |
| DrugBank | DB06785 |
| UNII ID | IX503L9WN0 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Orgalutran - Organon
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,083 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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166 adverse events reported
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