eltrombopag 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
thrombopoietin agonists	4399	496775-61-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: eltrombopag SB 497115 revolade eltrombopag olamine ppromacta	an oral, nonpeptide thrombopoietin receptor agonist Molecular weight: 442.48 Formula: C25H22N4O4 CLOGP: 5.25 LIPINSKI: 1 HAC: 8 HDO: 3 TPSA: 114.59 ALOGS: -4.63 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

eltrombopag
SB 497115
revolade
eltrombopag olamine
ppromacta

an oral, nonpeptide thrombopoietin receptor agonist

Molecular weight: 442.48
Formula: C25H22N4O4
CLOGP: 5.25
LIPINSKI: 1
HAC: 8
HDO: 3
TPSA: 114.59
ALOGS: -4.63
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
50	mg	O

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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Approvals:

Date	Agency	Company	Orphan
March 11, 2010	EMA
Nov. 20, 2008	FDA	NOVARTIS PHARMS CORP

FDA Adverse Event Reporting System (Female)

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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
Platelet count decreased	1511.80	18.31	643	12444	115479	63360456
Death	488.25	18.31	484	12603	373897	63102038
Platelet count increased	404.39	18.31	148	12939	17563	63458372
Platelet count abnormal	212.93	18.31	61	13026	3303	63472632
Product use in unapproved indication	210.91	18.31	220	12867	178860	63297075
Thrombocytopenia	196.66	18.31	196	12891	150961	63324974
Myelofibrosis	188.41	18.31	46	13041	1331	63474604
Haemorrhage	159.17	18.31	118	12969	60904	63415031
Petechiae	119.45	18.31	58	13029	13839	63462096
Thrombocytosis	119.40	18.31	45	13042	5773	63470162

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FDA Adverse Event Reporting System (Male)

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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
Platelet count decreased	808.75	18.49	466	9213	119251	34828001
Death	454.60	18.49	550	9129	397499	34549753
Platelet count abnormal	216.75	18.49	64	9615	2858	34944394
Platelet count increased	206.24	18.49	83	9596	9443	34937809
Product use in unapproved indication	170.29	18.49	185	9494	117314	34829938
Immune thrombocytopenia	145.39	18.49	64	9615	9088	34938164
Drug ineffective	116.14	18.49	331	9348	456420	34490832
Myelofibrosis	109.53	18.49	33	9646	1578	34945674
Therapy non-responder	91.00	18.49	80	9599	39066	34908186
Platelet disorder	70.57	18.49	24	9655	1697	34945555

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FDA Adverse Event Reporting System (Geriatric)

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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
Platelet count decreased	1375.67	16.48	720	16631	193944	79533093
Death	684.47	16.48	720	16631	565794	79161243
Platelet count increased	362.60	16.48	148	17203	22258	79704779
Platelet count abnormal	280.35	16.48	83	17268	4779	79722258
Product use in unapproved indication	278.43	16.48	306	17045	250053	79476984
Myelofibrosis	261.01	16.48	68	17283	2432	79724605
Petechiae	193.88	16.48	93	17258	20472	79706565
Immune thrombocytopenia	184.67	16.48	86	17265	17719	79709318
Thrombocytopenia	157.84	16.48	238	17113	265021	79462016
Haemorrhage	142.26	16.48	134	17217	90984	79636053

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B02BX05	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS VITAMIN K AND OTHER HEMOSTATICS Other systemic hemostatics
FDA EPC	N0000175973	Thrombopoietin Receptor Agonist
FDA MoA	N0000175968	Thrombopoietin Receptor Agonists
FDA MoA	N0000190107	Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA	N0000190113	Breast Cancer Resistance Protein Inhibitors
FDA MoA	N0000191272	UGT1A1 Inhibitors
FDA MoA	N0000191273	UGT2B7 Inhibitors
FDA MoA	N0000191274	UGT2B15 Inhibitors
FDA MoA	N0000191275	UGT1A3 Inhibitors
FDA MoA	N0000191276	UGT1A4 Inhibitors

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Chronic idiopathic thrombocytopenic purpura	indication	13172003
Thrombocytosis	contraindication	6631009	DOID:2228
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Acute hepatitis	contraindication	37871000
Hepatic vein thrombosis	contraindication	38739001	DOID:11512
Leukopenia	contraindication	84828003	DOID:615
Kidney disease	contraindication	90708001	DOID:557
Bilateral cataracts	contraindication	95722004
Myelodysplastic syndrome	contraindication	109995007
Liver function tests abnormal	contraindication	166603001

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.16	acidic
pKa2	3.76	acidic
pKa3	10.67	acidic
pKa4	1.34	Basic
pKa5	0.59	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7795293	May 21, 2023	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	7547719	July 13, 2025	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7795293	May 21, 2023	TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7547719	July 13, 2025	COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	7547719	July 13, 2025	PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PROMACTA	NOVARTIS	N022291	Nov. 16, 2012	DISCN	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID	PROMACTA	NOVARTIS	N022291	Oct. 20, 2011	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Sept. 27, 2018	RX	FOR SUSPENSION	ORAL	Nov. 16, 2025	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
EQ 25MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 25MG ACID/PACKET	PROMACTA KIT	NOVARTIS	N207027	Aug. 24, 2015	RX	FOR SUSPENSION	ORAL	Nov. 16, 2025	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
EQ 50MG ACID	PROMACTA	NOVARTIS	N022291	Nov. 20, 2008	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 75MG ACID	PROMACTA	NOVARTIS	N022291	Sept. 8, 2009	RX	TABLET	ORAL	Nov. 16, 2025	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Thrombopoietin receptor	Membrane receptor	P40238	TPOR_HUMAN	AGONIST	EC50	7.42	IUPHAR	IUPHAR
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	6.16	CHEMBL
ATP-binding cassette sub-family G member 2	Transporter	Q9UNQ0	ABCG2_HUMAN		IC50	5.51	CHEMBL

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External reference:

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ID	Source
012912	NDDF
012913	NDDF
135449332	PUBCHEM_CID
26020	MMSL
4028105	VUID
4028105	VANDF
432005001	SNOMEDCT_US
434132009	SNOMEDCT_US
441995009	SNOMEDCT_US
496775-62-3	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0684	TABLET, FILM COATED	12.50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0684	TABLET, FILM COATED	12.50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0684	TABLET, FILM COATED	12.50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0685	TABLET, FILM COATED	25 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0685	TABLET, FILM COATED	25 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0685	TABLET, FILM COATED	25 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0686	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0686	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0686	TABLET, FILM COATED	50 mg	ORAL	NDA	33 sections
PROMACTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0687	TABLET, FILM COATED	75 mg	ORAL	NDA	33 sections

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