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elagolix 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| gonadotropin releasing hormone (GnRH) antagonists | 5293 | 834153-87-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Elagolix is a GnRH receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.89 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,CDK5,EIF2AK3,GRK2,PDK1,PDK2,PDK4,PRKDC | 8 | |||
| kinase-selectivity-class | AXL,BRAF,CDK9,EIF2AK3,EPHB4,GRK2,MAP2K6,MAPK7,MET,PDK4,PIK3CD,SIK2,SIK3,TEK,ZAP70 | 15 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 23, 2018 | FDA | ABBVIE INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Bone density decreased | 272 | 49.22 | 64 | 1732 | 17281 | 90609370 |
| Suicidal ideation | 215.31 | 49.22 | 73 | 1723 | 73782 | 90552869 |
| Hot flush | 193.93 | 49.22 | 64 | 1732 | 59424 | 90567227 |
| Heavy menstrual bleeding | 153.65 | 49.22 | 42 | 1754 | 20488 | 90606163 |
| Depression | 104.62 | 49.22 | 68 | 1728 | 300533 | 90326118 |
| Maternal exposure during pregnancy | 93.48 | 49.22 | 68 | 1728 | 359995 | 90266656 |
| Nausea | 58.66 | 49.22 | 89 | 1707 | 1110227 | 89516424 |
| Headache | 58.54 | 49.22 | 78 | 1718 | 862668 | 89763983 |
| Mood swings | 54.38 | 49.22 | 19 | 1777 | 20683 | 90605968 |
| Hysterectomy | 52.21 | 49.22 | 16 | 1780 | 11568 | 90615083 |
| Dysmenorrhoea | 51.42 | 49.22 | 13 | 1783 | 4659 | 90621992 |
| Bone loss | 49.98 | 49.22 | 12 | 1784 | 3480 | 90623171 |
| Mood altered | 49.93 | 49.22 | 17 | 1779 | 17127 | 90609524 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Bone density decreased | 308.29 | 43.80 | 60 | 865 | 15982 | 110572392 |
| Hot flush | 107.24 | 43.80 | 34 | 891 | 66002 | 110522372 |
| Heavy menstrual bleeding | 90.15 | 43.80 | 22 | 903 | 16343 | 110572031 |
| Suicidal ideation | 87.94 | 43.80 | 32 | 893 | 93905 | 110494469 |
| Maternal exposure during pregnancy | 62.85 | 43.80 | 34 | 891 | 254849 | 110333525 |
| Depression | 61.13 | 43.80 | 36 | 889 | 317299 | 110271075 |
| Bone loss | 49.78 | 43.80 | 10 | 915 | 3045 | 110585329 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | H01CC03 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones |
| ATC | H01CC53 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones |
| FDA PE | N0000008638 | Decreased GnRH Secretion |
| FDA MoA | N0000175084 | Gonadotropin Releasing Hormone Receptor Antagonists |
| FDA EPC | N0000175839 | Gonadotropin Releasing Hormone Receptor Antagonist |
| FDA MoA | N0000182140 | Cytochrome P450 2C19 Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190118 | Cytochrome P450 3A Inducers |
Related Drugs by ATC class:
H01CC Anti-gonadotropin-releasing hormones 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Endometriosis | indication | 129103003 | |
| Hepatic failure | contraindication | 59927004 | |
| Osteoporosis | contraindication | 64859006 | DOID:11476 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.43 | acidic |
| pKa2 | 6.88 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | ORIAHNN (COPACKAGED) | ABBVIE | N213388 | May 29, 2020 | RX | CAPSULE | ORAL | 11459305 | Nov. 7, 2028 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) |
| EQ 150MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 7419983 | July 6, 2029 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS |
| EQ 200MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 7419983 | July 6, 2029 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS |
| EQ 150MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 11707464 | March 14, 2034 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX FOR UP TO 24 MONTHS |
| EQ 200MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 11344551 | March 14, 2034 | USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN HAVING DYSPAREUNIA ASSOCIATED WITH ENDOMETRIOSIS |
| EQ 200MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 11344551 | March 14, 2034 | USE OF ELAGOLIX 200 MG BID FOR 6 MONTHS TO MANAGE MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN PREMENOPAUSAL WOMEN TO REDUCE DYSMENORRHEA AND NON-MENSTRUAL PELVIC PAIN |
| EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | ORIAHNN (COPACKAGED) | ABBVIE | N213388 | May 29, 2020 | RX | CAPSULE | ORAL | 10881659 | March 14, 2034 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) |
| EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | ORIAHNN (COPACKAGED) | ABBVIE | N213388 | May 29, 2020 | RX | CAPSULE | ORAL | 11045470 | March 14, 2034 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) |
| EQ 150MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 10537572 | Sept. 1, 2036 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150MG ELAGOLIX WHILE CO-ADMINISTERING RIFAMPIN |
| EQ 150MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 10682351 | Sept. 1, 2036 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE |
| EQ 150MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 11690854 | April 19, 2038 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS IN A PATIENT WITH MODERATE HEPATIC IMPAIRMENT |
| EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | ORIAHNN (COPACKAGED) | ABBVIE | N213388 | May 29, 2020 | RX | CAPSULE | ORAL | 12083227 | Aug. 20, 2038 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) |
| EQ 150MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 11690845 | Aug. 27, 2040 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG OR 200 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE |
| EQ 200MG BASE | ORILISSA | ABBVIE | N210450 | July 23, 2018 | RX | TABLET | ORAL | 11690845 | Aug. 27, 2040 | MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG OR 200 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE |
| EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | ORIAHNN (COPACKAGED) | ABBVIE | N213388 | May 29, 2020 | RX | CAPSULE | ORAL | 11690845 | Aug. 27, 2040 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) USING 300 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Gonadotropin-releasing hormone receptor | GPCR | ANTAGONIST | IC50 | 8.82 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Kappa-type opioid receptor | GPCR | Ki | 5.62 | CHEMBL | |||||
| Gonadotropin-releasing hormone receptor | GPCR | Ki | 5.36 | CHEMBL | |||||
| Gonadotropin-releasing hormone receptor | GPCR | Ki | 8.48 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 5B2546MB5Z | UNII |
| 832720-36-2 | SECONDARY_CAS_RN |
| 4037713 | VANDF |
| C2714632 | UMLSCUI |
| CHEBI:177453 | CHEBI |
| F5O | PDB_CHEM_ID |
| CHEMBL1208155 | ChEMBL_ID |
| 11250647 | PUBCHEM_CID |
| DB11979 | DRUGBANK_ID |
| CHEMBL502182 | ChEMBL_ID |
| D09335 | KEGG_DRUG |
| 8983 | INN_ID |
| C539351 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8362 | IUPHAR_LIGAND_ID |
| 773185009 | SNOMEDCT_US |
| 773234007 | SNOMEDCT_US |
| 773235008 | SNOMEDCT_US |
| 286383 | MMSL |
| 34698 | MMSL |
| d08851 | MMSL |
| 017652 | NDDF |
| 017653 | NDDF |
| 2049846 | RXNORM |
| 5B2546MB5Z | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Orilissa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0038 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 31 sections |
| Orilissa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0039 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 31 sections |