Direct-acting antiviral agents

Qing XIe · Phase 2 active Small molecule

Direct-acting antiviral agents is a Direct-acting antiviral Small molecule drug developed by Qing XIe. It is currently in Phase 2 development for Hepatitis C, Hepatitis B. Also known as: daclatasvir, asunaprevir, ombitasvir, paritaprevir.

Direct-acting antiviral agents target viral replication by inhibiting viral enzymes or proteins.

Direct-acting antiviral agents target viral replication by inhibiting viral enzymes or proteins. Used for Hepatitis C, Hepatitis B.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Anti-infectives pathway favourability +2.0pp
  Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Direct-acting antiviral agents
Also known as	daclatasvir, asunaprevir, ombitasvir, paritaprevir, dasabuvir
Sponsor	Qing XIe
Drug class	Direct-acting antiviral
Target	Viral enzymes or proteins
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Direct-acting antiviral agents work by directly inhibiting viral enzymes or proteins, thereby blocking viral replication. This class of drugs includes protease inhibitors, polymerase inhibitors, and integrase inhibitors, among others.

Approved indications

• Hepatitis C
• Hepatitis B

Common side effects

• Fatigue
• Nausea
• Headache

Key clinical trials

• People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents (PHASE4)
• First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics (PHASE1)
• OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial (PHASE2)
• OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients (PHASE2)
• Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder (PHASE2, PHASE3)
• Drug-Drug Intercations and Direct Acting Antiviral Agents Against HCV
• HCV and Co-morbid Alcohol Use Disorders: A Translational Investigation of Antiviral Therapy Outcomes on CNS Function
• Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (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:

• Direct-acting antiviral agents CI brief — competitive landscape report
• Direct-acting antiviral agents updates RSS · CI watch RSS
• Qing XIe portfolio CI

Frequently asked questions about Direct-acting antiviral agents

What is Direct-acting antiviral agents?

Direct-acting antiviral agents is a Direct-acting antiviral drug developed by Qing XIe, indicated for Hepatitis C, Hepatitis B.

How does Direct-acting antiviral agents work?

Direct-acting antiviral agents target viral replication by inhibiting viral enzymes or proteins.

What is Direct-acting antiviral agents used for?

Direct-acting antiviral agents is indicated for Hepatitis C, Hepatitis B.

Who makes Direct-acting antiviral agents?

Direct-acting antiviral agents is developed by Qing XIe (see full Qing XIe pipeline at /company/qing-xie).

Is Direct-acting antiviral agents also known as anything else?

Direct-acting antiviral agents is also known as daclatasvir, asunaprevir, ombitasvir, paritaprevir, dasabuvir.

What drug class is Direct-acting antiviral agents in?

Direct-acting antiviral agents belongs to the Direct-acting antiviral class. See all Direct-acting antiviral drugs at /class/direct-acting-antiviral.

What development phase is Direct-acting antiviral agents in?

Direct-acting antiviral agents is in Phase 2.

What are the side effects of Direct-acting antiviral agents?

Common side effects of Direct-acting antiviral agents include Fatigue, Nausea, Headache.

What does Direct-acting antiviral agents target?

Direct-acting antiviral agents targets Viral enzymes or proteins and is a Direct-acting antiviral.

Related

• Drug class: All Direct-acting antiviral drugs
• Target: All drugs targeting Viral enzymes or proteins
• Manufacturer: Qing XIe — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for Hepatitis C
• Indication: Drugs for Hepatitis B
• Also known as: daclatasvir, asunaprevir, ombitasvir, paritaprevir, dasabuvir