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Sofosbuvir Oral Product
Sofosbuvir Oral Product is a Nucleotide analog NS5B polymerase inhibitor Small molecule drug developed by MTI University. It is currently FDA-approved for Chronic hepatitis C virus (HCV) infection, genotypes 1-6, in combination with other direct-acting antivirals. Also known as: Gratisovir.
Sofosbuvir is a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase that blocks viral replication.
Sofosbuvir is a small molecule inhibitor of RNA-directed RNA polymerase, classified as an INHIBITOR. It is used to treat conditions such as Chronic Hepatitis C, Chronic Hepatitis C Infection, HBV Coinfection, Hepatitis B Reactivation, and HIV-1 Infection.
At a glance
| Generic name | Sofosbuvir Oral Product |
|---|---|
| Also known as | Gratisovir |
| Sponsor | MTI University |
| Drug class | Nucleotide analog NS5B polymerase inhibitor |
| Target | HCV NS5B RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Sofosbuvir is a prodrug that is metabolized intracellularly to its active triphosphate form, which acts as a chain terminator when incorporated into the growing HCV RNA strand during replication. By inhibiting the NS5B polymerase, a critical enzyme for HCV genome replication, sofosbuvir prevents the virus from making copies of itself and establishing persistent infection.
Approved indications
- Chronic hepatitis C virus (HCV) infection, genotypes 1-6, in combination with other direct-acting antivirals
Common side effects
- Fatigue
- Headache
- Nausea
- Anemia
- Insomnia
Key clinical trials
- A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients (PHASE2)
- Implementing Low-Barrier HCV Treatment in a Jail Setting (PHASE4)
- Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy (PHASE4)
- C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV (PHASE3)
- Expanding the Pool in Orthotopic Heart Transplantation (PHASE2)
- C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV (PHASE3)
- Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan (NA)
- The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sofosbuvir Oral Product CI brief — competitive landscape report
- Sofosbuvir Oral Product updates RSS · CI watch RSS
- MTI University portfolio CI
Frequently asked questions about Sofosbuvir Oral Product
What is Sofosbuvir Oral Product?
How does Sofosbuvir Oral Product work?
What is Sofosbuvir Oral Product used for?
Who makes Sofosbuvir Oral Product?
Is Sofosbuvir Oral Product also known as anything else?
What drug class is Sofosbuvir Oral Product in?
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What are the side effects of Sofosbuvir Oral Product?
What does Sofosbuvir Oral Product target?
Related
- Drug class: All Nucleotide analog NS5B polymerase inhibitor drugs
- Target: All drugs targeting HCV NS5B RNA-dependent RNA polymerase
- Manufacturer: MTI University — full pipeline
- Therapeutic area: All drugs in Virology / Hepatology
- Indication: Drugs for Chronic hepatitis C virus (HCV) infection, genotypes 1-6, in combination with other direct-acting antivirals
- Also known as: Gratisovir
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing