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Daclatasvir Dihydrochloride

Daclatasvir Dihydrochloride structure

CAS No:
1009119-65-6
Formula:
C40H51ClN8O6
Chemical Name:
Daclatasvir Dihydrochloride
Synonyms:
BMS 790052;BMS-790052;BMS790052 ;BMS 790052;DACLATASVIR;BMS-790052 DIHYDROCHLORIDE;BMS790052 DIHYDROCHLORIDE;BMS 790052 DIHYDROCHLORIDE;BMS-790052; BMS790052 ; BMS 790052;DACLATASVIR;Daclatasvir dihydrochloride (BMS-790052);BMS 790052 (di HClsalt);N,N'-[[1,1'-Biphenyl]-4,4'-diylbis[1H-imidazole-5,2-diyl-(2S)-2,1-pyrrolidinediyl[(1S)-1-(1-methylethyl)-;Daclatasvir dihydrochloride (BMS-790052 dihydrochloride);Dacatavir dihydrochloride
Categories:
Pharmaceutical Intermediates > Bulk Drug Intermediates

Description

Daclatasvir hydrochloride is a hydrochloride obtained by combining daclatasvir with two molar equivalents of hydrochloric acid. It is a potent inhibitor of nonstructural protein 5A and is used for treatment of hepatitis C. It has a role as an antiviral drug and a nonstructural protein 5A inhibitor. It contains a daclatasvir(2+).|Daclatasvir Dihydrochloride is the dihydrochloride salt form of daclatasvir, an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Although the exact mechanism of action of daclatasvir has yet to be fully determined, this agent, upon oral administration and after intracellular uptake, appears to bind to domain I of the NS5A protein. This inhibits the activity of the NS5A protein and results in the disruption of the viral RNA replication complex, blockage of viral HCV RNA production, and inhibition of viral replication. NS5A, a zinc-binding and proline-rich hydrophilic phosphoprotein, plays a crucial role in HCV RNA replication. HCV is a small, enveloped, single-stranded RNA virus belonging to the Flaviviridae family.

Daclatasvir dihydrochloride is a hepatitis C virus nonstructural 5A (NS5A) replication complex inhibitor which was first approved in Japan for the treatment of genotype 1 HCV patients who fail to respond to interferon plus ribavirin. The drug has also been approved for patients with untreated, chronic HCV who are eligible for interferon. Additionally, in Europe, daclatasvir was approved for use in combination with other products across genotype 1–4 HCV. Daclatasvir was discovered and developed by Bristol–Myers Squibb and a fascinating account describing the initiation of the program from a phenotypic screen and the medicinal chemistry strategy leading to the discovery of the compound has been recently reported.

Daclatasvir dihydrochloride is white to yellow powder. It is freely soluble in water (>700 mg/mL). The solubility is strongly pH-dependent and the solubility is high at low pH values.

Daclatasvir Dihydrochloride Basic Attributes

Molecular Weight：

775.35

Exact Mass：

810.3386868

EC Number：

816-965-3

UNII：

50ZO25C11D

NCI Thesaurus Code：

C166798

Color/Form：

Off-White to Yellow

ATC Code：

J05AP07

Characteristics

Melting Point：

>207°C (dec.)

Critical Temperature & Pressure：

-20°C Freezer

Safety Information

GHS Classification：

|Warning|H317 (100%): May cause an allergic skin reaction [Warning Sensitization, Skin]|P260, P261, P264, P271, P272, P280, P302+P352, P304+P340, P305+P351+P338, P312, P314, P321, P333+P313, P337+P313, P363, P403+P233, P405, and P501|The GHS information provided by 1 company from 1 notification to the ECHA C&L Inventory.

Drug Information

Drug Indication：

Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1)., , For HCV genotype specific activity, see sections 4.4 and 5.1.,|Treatment of chronic hepatitis C

MeSH Entry Terms：

BMS-790052

Daclatasvir Dihydrochloride Use and Manufacturing

Uses

Daclatasvir Dihydrochloride is the dihydrochloride salt form of daclatasvir, an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Daclatasvir is used with another antiviral medication (sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Daclatasvir should never be used without sofosbuvir. Daclatasvir and sofosbuvir may also be used with another antiviral medication (ribavirin).

Use Classification：

Human drugs -> Daklinza -> EMA Drug Category|Antivirals for systemic use -> Human pharmacotherapeutic group|Human Drugs -> EU pediatric investigation plans|Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients

Related Drugs

Daclatasvir Hydrochloride Tablets
Ingredients	Daclatasvir hydrochloride.
Indication	Possible effects of other drugs on daclatasvir hydrochloride tablets Daclatasvir hydrochloride is a CYP3A4 substrate. Moderate or strong CYP3A4 inducers may reduce the plasma levels and therapeutic effects of daclatasvir hydrochloride (see [Contraindications] and Table 12). When used in combination with moderate CYP3A4 inducers, the dose of daclatasvir hydrochloride tablets should be increased to 90 mg daily (3 30 mg tablets or 1 tablet each of 60 mg and 30 mg tablets). Strong CYP3A4 inhibitors may increase the plasma levels of daclatasvir hydrochloride (see Table 12). When used in combination with strong CYP3A4 inhibitors, the dose of daclatasvir hydrochloride tablets should be reduced to 30 mg daily. Daclatasvir hydrochloride is also a substrate of P-glycoprotein transporter (P-gp) and organic cation transporter (OCT) 1.
Specifications	60mg*14s

Registered Holders

MSN LIFE SCIENCES PRIVATE LTD

United States
Active
ALIVUS LIFE SCIENCES LTD

United States
Active
HETERO LABS LTD

United States
Active

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Guide of Daclatasvir Dihydrochloride

Description
Basic Attributes
Characteristics
Safety Information
Drug Information
Use and Manufacturing
Related Drugs
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