- Raw materials
- Elbasvir
Filters
Filter
Custom request?
Type
Production region
Qualifications
Country of origin
Elbasvir API Manufacturers & Suppliers
2 verified results
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
Commercial-scale Suppliers
Producer
Produced in
China|
Employees: 60
|
Audit Report:
Certifications:
CoA
All certificates
CoA
Producer
Produced in
China|
Employees: 3500
|
Audit Report:
Certifications:
MSDS
|
ISO9001|
WC|
CoAAll certificates
MSDS
ISO9001
WC
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Get full market intelligence report
€399,-
All Elbasvir data. Full access. Full negotiation power
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency
|
Supplier trade data access
|
Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Elbasvir | CAS No: 1370468-36-2 | GMP-certified suppliers
A medication that treats chronic hepatitis C virus genotypes 1 and 4 infections, providing antiviral effects to support sustained virologic response and reduced liver-related complications.
Therapeutic categories
Antiinfectives for Systemic UseAntiviral AgentsAntivirals for Systemic UseAntivirals for treatment of HCV infectionsBCRP/ABCG2 InhibitorsCytochrome P-450 CYP3A Inhibitors
Generic name
Elbasvir
Molecule type
small molecule
CAS number
1370468-36-2
DrugBank ID
DB11574
Approval status
Approved drug
ATC code
J05AP54
Primary indications
- Elbasvir, when used in combination with [grazoprevir] as the combination product Zepatier, is indicated for use with or without [ribavirin] for the treatment of chronic HCV genotypes 1 or 4 infection in adults
Product Snapshot
- Elbasvir is an oral small molecule available in coated tablet formulations
- It is primarily used in combination therapy for the treatment of chronic hepatitis C virus genotypes 1 and 4 infection
- Elbasvir has received regulatory approval in the US, Canada, and European Union markets
Clinical Overview
Elbasvir is a direct-acting antiviral agent used in combination therapy for the treatment of chronic hepatitis C virus (HCV) infection, specifically targeting genotypes 1 and 4. It functions as a non-structural protein 5A (NS5A) inhibitor, a viral protein essential for HCV replication and virion assembly. Although the precise molecular role of NS5A remains incompletely characterized, elbasvir’s inhibition disrupts multiple processes critical to the HCV life cycle, including signaling pathways, localization of NS5A from the endoplasmic reticulum to lipid droplets, and modulation of the viral replication complex.
Elbasvir is most commonly administered as part of a fixed-dose combination with grazoprevir (tradename Zepatier), with or without ribavirin, depending on the presence of resistance-associated substitutions in NS5A and prior treatment history. Approved by the U.S. Food and Drug Administration in 2016, this combination has demonstrated sustained virologic response (SVR) rates between 94% and 100% following 12 weeks of therapy in patients infected with genotypes 1 and 4. Achieving SVR is associated with decreased liver-related morbidity, reduced incidence of hepatocellular carcinoma, and lower overall mortality.
Key pharmacokinetic and metabolic characteristics include substrate and inhibitor activity against cytochrome P450 CYP3A isoenzymes and involvement in P-glycoprotein transport. Elbasvir’s resistance profile is marked by specific amino acid substitutions at positions 28, 30, 31, and 93 of the NS5A protein, which can confer reduced susceptibility. Close monitoring for resistance-associated variants is crucial for appropriate regimen selection.
Safety considerations include potential hepatotoxicity and drug-drug interactions mediated via CYP3A. Elbasvir-based regimens are contraindicated with strong CYP3A inducers. Ongoing assessment of baseline viral resistance markers informs optimal use.
Elbasvir is a synthetic valine derivative with a CAS Registry Number of 1370468-36-2. For API sourcing, procurement should emphasize compliance with current Good Manufacturing Practice (cGMP) standards and confirm identity, purity, and stability through validated analytical methods to ensure consistent quality suitable for pharmaceutical formulation and clinical use.
Elbasvir is most commonly administered as part of a fixed-dose combination with grazoprevir (tradename Zepatier), with or without ribavirin, depending on the presence of resistance-associated substitutions in NS5A and prior treatment history. Approved by the U.S. Food and Drug Administration in 2016, this combination has demonstrated sustained virologic response (SVR) rates between 94% and 100% following 12 weeks of therapy in patients infected with genotypes 1 and 4. Achieving SVR is associated with decreased liver-related morbidity, reduced incidence of hepatocellular carcinoma, and lower overall mortality.
Key pharmacokinetic and metabolic characteristics include substrate and inhibitor activity against cytochrome P450 CYP3A isoenzymes and involvement in P-glycoprotein transport. Elbasvir’s resistance profile is marked by specific amino acid substitutions at positions 28, 30, 31, and 93 of the NS5A protein, which can confer reduced susceptibility. Close monitoring for resistance-associated variants is crucial for appropriate regimen selection.
Safety considerations include potential hepatotoxicity and drug-drug interactions mediated via CYP3A. Elbasvir-based regimens are contraindicated with strong CYP3A inducers. Ongoing assessment of baseline viral resistance markers informs optimal use.
Elbasvir is a synthetic valine derivative with a CAS Registry Number of 1370468-36-2. For API sourcing, procurement should emphasize compliance with current Good Manufacturing Practice (cGMP) standards and confirm identity, purity, and stability through validated analytical methods to ensure consistent quality suitable for pharmaceutical formulation and clinical use.
Identification & chemistry
| Generic name | Elbasvir |
|---|---|
| Molecule type | Small molecule |
| CAS | 1370468-36-2 |
| UNII | 632L571YDK |
| DrugBank ID | DB11574 |
Pharmacology
| Summary | Elbasvir is a direct-acting antiviral targeting the hepatitis C virus (HCV) non-structural protein 5A (NS5A), which is critical for viral replication and virion assembly. By inhibiting NS5A, elbasvir disrupts viral RNA replication complexes and impairs viral lifecycle processes. Computational studies also indicate potential activity against key replication proteins of SARS-CoV-2, although clinical efficacy in this context remains unconfirmed. |
|---|---|
| Mechanism of action | Elbasvir is an inhibitor of the HCV non-structural protein 5A. While the precise role of this protein is unknown, it is essential to viral replication and virion assembly.[synthesis] Potential modes of action of NS5A inhibitors like elbasvir include blocking signaling interactions, redistribution of NS5A from the endoplasmic reticulum to the surface of lipid droplets, and modification of the HCV replication complex. Computational target-based _in silico_ research suggests that elbasvir may carry activity at several proteins required for replication of SARS-CoV-2 - namely RNA-dependent RNA polymerase, helicase, and papain-like proteinase - although specific activity has yet to be affirmed by follow-up clinical studies. |
| Pharmacodynamics | Elbasvir is classified as a direct-acting antiviral (DAA) and prevents viral replication in HCV genotypes 1a, 1b, and 4. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Nonstructural protein 5A | Hepatitis C Virus | inhibitor |
ADME / PK
| Absorption | Elbasvir reaches peak plasma concentration 3-6 hours after administration and has an absolute bioavailability of 32%. When co-administered with food, the peak concentration of elbasvir increases 1.5-fold, but this increase in exposure is not likely to be clinically relevant. |
|---|---|
| Half-life | The geometric mean apparent terminal half-life for elbasvir is 24 hours in HCV-infected subjects. |
| Protein binding | Elbasvir is more than 99.9% bound to plasma proteins. It binds both human serum albumin and α1-acid glycoprotein. |
| Metabolism | Elbasvir is partially eliminated by oxidative metabolism meditated by CYP3A. No circulating metabolites of elbasvir have been detected in human plasma. |
| Route of elimination | Elbasvir is mainly eliminated in the feces (90%) with very little eliminated in the urine (<1%). |
| Volume of distribution | Elbasvir has an estimated apparent volume of distribution of 680 liters. It is thought to distribute into most tissues including the liver. |
| Clearance | The clearance of elbasvir has not been determined. |
Formulation & handling
- Elbasvir is a small molecule API formulated exclusively for oral administration in coated tablet forms.
- Its high lipophilicity and very low water solubility require careful consideration of formulation to optimize bioavailability.
- Be aware of CYP3A-mediated food and herb interactions, notably contraindicating St. John’s Wort and advising caution with grapefruit products.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is protected by patents expiring in the United States in 2029 and 2031, with products currently marketed in the US, Canada, and the EU. Market presence in these regions indicates an established lifecycle stage with forthcoming patent expirations. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Elbasvir is primarily marketed under the brand name Zepatier in the US, Canada, and EU markets, indicating a dominant originator company presence. The existing patents in the United States extend until 2029 and 2031, suggesting that generic competition is expected to emerge only after these expiration dates. Currently, branded products maintain a strong global presence in these key markets. |
|---|
Safety
| Toxicity | The most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache, and nausea. |
|---|
High Level Warnings:
- 1
- Handle with appropriate personal protective equipment to minimize exposure, as fatigue, headache, and nausea are reported adverse reactions in clinical settings
- 2
Elbasvir API manufacturers & distributors
Compare qualified Elbasvir API suppliers worldwide. We currently have 2 companies offering Elbasvir API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ChemExpress | Producer | United States | China | CoA, ISO9001, MSDS, WC | 197 products |
| Hangzhou Jinlan Pharm-Dru... | Producer | China | China | CoA | 40 products |
When sending a request, specify which Elbasvir API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Elbasvir API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
