Rifapentine (RPT)

Walter K. Kraft · Phase 3 active Small molecule

Rifapentine (RPT) is a Rifamycin antibiotic Small molecule drug developed by Walter K. Kraft. It is currently in Phase 3 development for Tuberculosis (TB), including drug-susceptible and latent TB infection, Pulmonary tuberculosis as part of combination therapy. Also known as: Priftin, Rifamycin.

Rifapentine inhibits bacterial RNA polymerase, preventing transcription and killing or stopping the growth of mycobacteria.

Rifapentine inhibits bacterial RNA polymerase, preventing transcription and killing or stopping the growth of mycobacteria. Used for Tuberculosis (TB), including drug-susceptible and latent TB infection, Pulmonary tuberculosis as part of combination therapy.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• 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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Rifapentine (RPT)
Also known as	Priftin, Rifamycin
Sponsor	Walter K. Kraft
Drug class	Rifamycin antibiotic
Target	Bacterial RNA polymerase
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 3

Mechanism of action

Rifapentine is a rifamycin antibiotic that binds to the bacterial RNA polymerase enzyme and blocks RNA synthesis in mycobacteria. It has a longer half-life than rifampicin, allowing for less frequent dosing. It is bactericidal against Mycobacterium tuberculosis and is used as part of combination therapy for tuberculosis.

Approved indications

• Tuberculosis (TB), including drug-susceptible and latent TB infection
• Pulmonary tuberculosis as part of combination therapy

Common side effects

• Hepatotoxicity
• Hyperuricemia
• Gastrointestinal disturbances
• Rash
• Drug interactions (enzyme induction)

Key clinical trials

• A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV (PHASE1, PHASE2)
• One-month Latent Tuberculosis Treatment for Renal Transplant Candidates (PHASE4)
• Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV (PHASE1, PHASE2)
• Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis (PHASE2)
• 1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam (PHASE3)
• Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals (PHASE3)
• Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT (PHASE3)
• Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention (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:

• Rifapentine (RPT) CI brief — competitive landscape report
• Rifapentine (RPT) updates RSS · CI watch RSS
• Walter K. Kraft portfolio CI

Frequently asked questions about Rifapentine (RPT)

What is Rifapentine (RPT)?

Rifapentine (RPT) is a Rifamycin antibiotic drug developed by Walter K. Kraft, indicated for Tuberculosis (TB), including drug-susceptible and latent TB infection, Pulmonary tuberculosis as part of combination therapy.

How does Rifapentine (RPT) work?

Rifapentine inhibits bacterial RNA polymerase, preventing transcription and killing or stopping the growth of mycobacteria.

What is Rifapentine (RPT) used for?

Rifapentine (RPT) is indicated for Tuberculosis (TB), including drug-susceptible and latent TB infection, Pulmonary tuberculosis as part of combination therapy.

Who makes Rifapentine (RPT)?

Rifapentine (RPT) is developed by Walter K. Kraft (see full Walter K. Kraft pipeline at /company/walter-k-kraft).

Is Rifapentine (RPT) also known as anything else?

Rifapentine (RPT) is also known as Priftin, Rifamycin.

What drug class is Rifapentine (RPT) in?

Rifapentine (RPT) belongs to the Rifamycin antibiotic class. See all Rifamycin antibiotic drugs at /class/rifamycin-antibiotic.

What development phase is Rifapentine (RPT) in?

Rifapentine (RPT) is in Phase 3.

What are the side effects of Rifapentine (RPT)?

Common side effects of Rifapentine (RPT) include Hepatotoxicity, Hyperuricemia, Gastrointestinal disturbances, Rash, Drug interactions (enzyme induction).

What does Rifapentine (RPT) target?

Rifapentine (RPT) targets Bacterial RNA polymerase and is a Rifamycin antibiotic.

Related

• Drug class: All Rifamycin antibiotic drugs
• Target: All drugs targeting Bacterial RNA polymerase
• Manufacturer: Walter K. Kraft — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for Tuberculosis (TB), including drug-susceptible and latent TB infection
• Indication: Drugs for Pulmonary tuberculosis as part of combination therapy
• Also known as: Priftin, Rifamycin