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DCV 3DAA FDC
DCV 3DAA FDC is a Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 1 development. Also known as: Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | DCV 3DAA FDC |
|---|---|
| Also known as | Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 |
| Sponsor | Bristol-Myers Squibb |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C (PHASE3)
- Study of Drug Combination on Pharmacokinetics in Healthy Volunteers (PHASE1)
- Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (PHASE1)
- Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325 (PHASE1)
- To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet (PHASE1)
- Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects (PHASE1)
- Drug Interaction & Methadone & Buprenorphine (PHASE1)
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:
- DCV 3DAA FDC CI brief — competitive landscape report
- DCV 3DAA FDC updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about DCV 3DAA FDC
What is DCV 3DAA FDC?
Who makes DCV 3DAA FDC?
Is DCV 3DAA FDC also known as anything else?
What development phase is DCV 3DAA FDC in?
Related
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Also known as: Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing