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Efavirenz-based regimens
Efavirenz-based regimens is a Small molecule drug developed by Fundação Bahiana de Infectologia. It is currently in Phase 2 development. Also known as: Efavirenz, Stocrin, Sustiva.
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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).
| 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 | Efavirenz-based regimens |
|---|---|
| Also known as | Efavirenz, Stocrin, Sustiva |
| Sponsor | Fundação Bahiana de Infectologia |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (PHASE3)
- Extended Duration Artemether-lumefantrine Treatment for Malaria in Children (PHASE4)
- Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (PHASE3)
- Antimalarial Pharmacology in Children and Pregnant Women in Uganda
- Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients (PHASE2, PHASE3)
- A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy (PHASE2)
- Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection (PHASE1, PHASE2)
- Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease (PHASE4)
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:
- Efavirenz-based regimens CI brief — competitive landscape report
- Efavirenz-based regimens updates RSS · CI watch RSS
- Fundação Bahiana de Infectologia portfolio CI
Frequently asked questions about Efavirenz-based regimens
What is Efavirenz-based regimens?
Who makes Efavirenz-based regimens?
Is Efavirenz-based regimens also known as anything else?
What development phase is Efavirenz-based regimens in?
Related
- Manufacturer: Fundação Bahiana de Infectologia — full pipeline
- Also known as: Efavirenz, Stocrin, Sustiva
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing