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Antiretrovirals
Antiretrovirals is a Small molecule drug developed by Code Pharma. It is currently in Phase 2 development. Also known as: Genvoya, Stribild, ART.
Antiretrovirals are used to control HIV infection through a strategy that involves the use of multiple drugs acting on different stages of the replication cycle of HIV. Highly active antiretroviral therapy (HAART) involves the use of multiple drugs that act on different viral targets, which decreases the patient's total burden.
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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.
| 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 | Antiretrovirals |
|---|---|
| Also known as | Genvoya, Stribild, ART |
| Sponsor | Code Pharma |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003) (PHASE1)
- Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy (PHASE1)
- Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy
- Opioid, HIV and Immune System (PHASE4)
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2, PHASE3)
- CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)
- Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption (PHASE2)
- Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India (NA)
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:
- Antiretrovirals CI brief — competitive landscape report
- Antiretrovirals updates RSS · CI watch RSS
- Code Pharma portfolio CI
Frequently asked questions about Antiretrovirals
What is Antiretrovirals?
Who makes Antiretrovirals?
Is Antiretrovirals also known as anything else?
What development phase is Antiretrovirals in?
Related
- Manufacturer: Code Pharma — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Also known as: Genvoya, Stribild, ART
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing