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

Stem definition	Drug id	CAS RN
	4677	26833-87-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: omacetaxine mepesuccinate synribo homoharringtonine CGX-635 NSC 141633 NSC-141633	Semisynthetic derivative of harringtonine that acts as a protein synthesis inhibitor and induces APOPTOSIS in tumor cells. It is used in the treatment of MYELOID LEUKEMIA, CHRONIC. Molecular weight: 545.63 Formula: C29H39NO9 CLOGP: 1.76 LIPINSKI: 1 HAC: 10 HDO: 2 TPSA: 123.99 ALOGS: -3.70 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

omacetaxine mepesuccinate
synribo
homoharringtonine
CGX-635
NSC 141633
NSC-141633

Semisynthetic derivative of harringtonine that acts as a protein synthesis inhibitor and induces APOPTOSIS in tumor cells. It is used in the treatment of MYELOID LEUKEMIA, CHRONIC.

Molecular weight: 545.63
Formula: C29H39NO9
CLOGP: 1.76
LIPINSKI: 1
HAC: 10
HDO: 2
TPSA: 123.99
ALOGS: -3.70
ROTB: 11

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	9.80 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.96 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1.80 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Oct. 26, 2012	FDA	IVAX INTL

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
Bone marrow failure	70.83	43.14	21	571	29269	63459161
Platelet count decreased	64.78	43.14	28	564	116094	63372336
Myelosuppression	61.69	43.14	18	574	23685	63464745
Injection site erythema	49.40	43.14	21	571	83153	63405277
Nausea	47.57	43.14	48	544	854423	62634007

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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
Myelosuppression	90.23	46.46	26	533	19239	34937133
Injection site erythema	54.95	46.46	17	542	15882	34940490
Platelet count decreased	46.94	46.46	27	532	119690	34836682

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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
Myelosuppression	145.11	42.37	42	956	40254	79703136
Platelet count decreased	86.64	42.37	44	954	194620	79548770
Nausea	80.44	42.37	77	921	957119	78786271
Bone marrow failure	78.83	42.37	28	970	51079	79692311
Injection site erythema	54.04	42.37	24	974	78173	79665217

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01XX40	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:48001	protein synthesis inhibitors
CHEBI has role	CHEBI:68495	Type I cell-death inducers
CHEBI has role	CHEBI:149553	anticoronaviral drug
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000972	Antineoplastic Agents, Phytogenic
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D011500	Protein Synthesis Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Chronic myeloid leukemia	indication	92818009	DOID:8552

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.86	acidic
pKa2	8.15	Basic

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
3.5MG/VIAL	SYNRIBO	TEVA PHARMS INTL	N203585	Oct. 26, 2012	RX	POWDER	SUBCUTANEOUS	6987103	Oct. 26, 2026	TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

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ID	Source
HMT	PDB_CHEM_ID
009753	NDDF
1356689	RXNORM
194347	MMSL
24316-19-6	SECONDARY_CAS_RN
27023	MMSL
285033	PUBCHEM_CID
4031782	VUID
4031782	VANDF
4031814	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
SYNRIBO	HUMAN PRESCRIPTION DRUG LABEL	1	63459-177	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	SUBCUTANEOUS	NDA	27 sections
SYNRIBO	HUMAN PRESCRIPTION DRUG LABEL	1	63459-177	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	SUBCUTANEOUS	NDA	27 sections

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