Last reviewed · How we verify
Antiviral Agents
Antiviral Agents is a Antiviral agent Small molecule drug developed by Pregistry. It is currently in Phase 3 development. Also known as: Veklury (remdesivir), Lagevrio (molnupiravir), Nucleoside analogue, Nucleotide analogue.
Antiviral agents work by inhibiting viral replication through various mechanisms such as blocking viral enzymes, preventing viral entry, or interfering with viral protein synthesis.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Antiviral Agents |
|---|---|
| Also known as | Veklury (remdesivir), Lagevrio (molnupiravir), Nucleoside analogue, Nucleotide analogue, Peginterferon |
| Sponsor | Pregistry |
| Drug class | Antiviral agent |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Antiviral agents represent a broad class of drugs that target different stages of the viral life cycle. Depending on the specific agent, they may inhibit viral proteases, reverse transcriptases, neuraminidases, or other essential viral proteins. The exact mechanism depends on the particular antiviral compound being developed by Pregistry in their Phase 3 program.
Approved indications
Common side effects
Key clinical trials
- This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza (PHASE2)
- The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster (NA)
- A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease (PHASE3)
- Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP (PHASE3)
- A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine (PHASE1)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
- People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents (PHASE4)
- Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
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:
- Antiviral Agents CI brief — competitive landscape report
- Antiviral Agents updates RSS · CI watch RSS
- Pregistry portfolio CI
Frequently asked questions about Antiviral Agents
What is Antiviral Agents?
How does Antiviral Agents work?
Who makes Antiviral Agents?
Is Antiviral Agents also known as anything else?
What drug class is Antiviral Agents in?
What development phase is Antiviral Agents in?
Related
- Drug class: All Antiviral agent drugs
- Manufacturer: Pregistry — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Also known as: Veklury (remdesivir), Lagevrio (molnupiravir), Nucleoside analogue, Nucleotide analogue, Peginterferon
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing