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Rifafour
Rifafour is a Small molecule drug developed by Global Alliance for TB Drug Development. It is currently in Phase 2 development.
Rifafour e-275 mg is an intervention being studied in clinical trials for conditions such as Pulmonary Tuberculosis, Disseminated Tuberculosis, HIV, and Tuberculosis. It is being evaluated in combination with other treatments, including PA-824 and Rifampin, as part of a Phase IIa trial to assess its safety, tolerability, and early bactericidal activity.
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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 | Rifafour |
|---|---|
| Sponsor | Global Alliance for TB Drug Development |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
- Elevated uric acid
- Decreased hemoglobin level
- Elevated creatinine kinase
- Elevated liver enzymes (ALT/AST)
Key clinical trials
- Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis (PHASE3)
- Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis (PHASE2)
- A Pan-TB Regimen Targeting Host and Microbe (PHASE2, PHASE3)
- Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis (PHASE2)
- An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis (PHASE2)
- StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis (PHASE2)
- Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis (PHASE2)
- BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) (PHASE1, PHASE2)
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:
- Rifafour CI brief — competitive landscape report
- Rifafour updates RSS · CI watch RSS
- Global Alliance for TB Drug Development portfolio CI
Frequently asked questions about Rifafour
What is Rifafour?
Who makes Rifafour?
What development phase is Rifafour in?
What are the side effects of Rifafour?
Related
- Manufacturer: Global Alliance for TB Drug Development — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing