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Optimised dose rifampicin
Optimised dose rifampicin is a Antibiotic (rifamycin) Small molecule drug developed by Radboud University Medical Center. It is currently in Phase 3 development for Tuberculosis (optimised dosing regimen).
Optimised dose rifampicin inhibits bacterial RNA polymerase to suppress mycobacterial protein synthesis and growth.
Rifampicin is a small molecule that inhibits bacterial DNA-directed RNA polymerase, classified as an inhibitor. It is being studied in clinical trials, including the Pragmatic Optimized Rifampicin Trial (PORT), for its safety and tolerability in treating conditions such as tuberculosis and pulmonary tuberculosis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Optimised dose rifampicin |
|---|---|
| Sponsor | Radboud University Medical Center |
| Drug class | Antibiotic (rifamycin) |
| Target | Bacterial RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Rifampicin is a well-established antibiotic that binds to bacterial RNA polymerase, blocking transcription and translation in mycobacteria. The optimised dosing regimen aims to improve pharmacokinetic exposure and efficacy while maintaining tolerability in tuberculosis treatment. This approach seeks to enhance bacterial killing and potentially shorten treatment duration.
Approved indications
- Tuberculosis (optimised dosing regimen)
Common side effects
- Hepatotoxicity
- Gastrointestinal disturbance
- Rash
- Drug-drug interactions
Key clinical trials
- AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT (PHASE2)
- Pragmatic Optimized Rifampicin Trial (PHASE3)
- PanACEA - STEP2C -01 (PHASE2)
- A Pragmatic Trial With Optimized Dose of Rifampicin and Moxifloxacin for the Treatment of Drug Susceptible Pulmonary Tuberculosis (PHASE3)
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:
- Optimised dose rifampicin CI brief — competitive landscape report
- Optimised dose rifampicin updates RSS · CI watch RSS
- Radboud University Medical Center portfolio CI
Frequently asked questions about Optimised dose rifampicin
What is Optimised dose rifampicin?
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What does Optimised dose rifampicin target?
Related
- Drug class: All Antibiotic (rifamycin) drugs
- Target: All drugs targeting Bacterial RNA polymerase
- Manufacturer: Radboud University Medical Center — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Tuberculosis (optimised dosing regimen)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing