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Rezolsta
Rezolsta is a Small molecule drug developed by St Stephens Aids Trust. It is currently in Phase 1 development. Also known as: darunavir/cobicistat, darunavir and cobicistat.
Rezolsta is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains darunavir, an HIV protease inhibitor, and cobicistat, which increases the effectiveness of darunavir by blocking its metabolism.
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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).
| 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 | Rezolsta |
|---|---|
| Also known as | darunavir/cobicistat, darunavir and cobicistat |
| Sponsor | St Stephens Aids Trust |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants (PHASE1)
- National Multicenter Trial Evaluating Two Treatments in Patients with Primary Human Immunodeficiency Virus (HIV-1) Infection (PHASE3)
- Darunavir/Cobicistat vs. Lopinavir/Ritonavir in COVID-19 Pneumonia in Qatar
- Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI). (PHASE4)
- Optimization of Darunavir Therapy and Dosage Recommendations (PHASE4)
- The Pharmacokinetics of Dolutegravir, Darunavir/Cobocistat When Co-administered in Healthy Volunteers (PHASE1)
- Study in HIV1-Positive, Virosuppressed Patients Currently inTreatment With Ritonavir-Boosted Protease Inhibitors (PI/r) Starting Cobicistat-Boosted Darunavir (DRV/c - Rezolsta)
- Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients (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:
- Rezolsta CI brief — competitive landscape report
- Rezolsta updates RSS · CI watch RSS
- St Stephens Aids Trust portfolio CI
Frequently asked questions about Rezolsta
What is Rezolsta?
Who makes Rezolsta?
Is Rezolsta also known as anything else?
What development phase is Rezolsta in?
Related
- Manufacturer: St Stephens Aids Trust — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: darunavir/cobicistat, darunavir and cobicistat
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing