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Priftin

(Rifapentine)

ApprovedSmall molecule

Rifapentine is used to treat tuberculosis (TB), a serious lung infection. It works by killing the bacteria that cause TB and is often used as part of a combination treatment with other TB medications.[2] Priftin is currently approved and in use across 6 indications[4].[1]

Priftin is one of 153 small molecule programs targeting Tics. It is currently in Approved.

6

Indications

34

Total Trials

7

Active Trials

152

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

TicsActive, not recruiting

Macular DegenerationActive, not recruiting

Pulmonary TuberculosisApproved

OsteomyelitisApproved

TuberculosisTerminated

Pediatric HIV InfectionRecruiting

TicsPhase 2

Active, not recruiting

Macular DegenerationPreclinical

Active, not recruiting

Pulmonary TuberculosisApproved

Approved

OsteomyelitisApproved

Approved

TuberculosisApproved

Terminated

Pediatric HIV InfectionPhase 1

Recruiting

Competition

Competitive Landscape

108 competitors in Tics

#DrugCompanyPhaseTrials

Priftin

Sodium Valproate

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Duvyzat

Dilaudid

RRhodes Pharmaceuticals, L.P.

Aciphex

Akero Therapeutics

Invokana

Tylenol

Rifampicin

Boehringer Ingelheim

Abexinostat

XXynomic Pharmaceuticals, Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Recruiting

Pediatric HIV Infection

NCT06281834

Q3 2027

Phase 3Recruiting

Tuberculosis

NCT06253715

Q4 2028

PreclinicalRecruiting

Tuberculosis

NCT07124559

Q4 2029

Phase 2Not yet recruiting

Tuberculosis

NCT07595042

Phase 2Not yet recruiting

Tuberculosis

NCT06917495

Clinical

Trials by Indication[1]

Tuberculosis14 trials

Treatment of Latent Tuberculosis in Socially Marginalised Citizens

Terminated·—·Phase 4·NCT03266991·22 enrolled

Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

Completed·YYale University·N/A·NCT03089983·316 enrolled

Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis

Completed·UUniversity College, London·Phase 2/3·NCT03474198·675 enrolled

Show 11 more trials

Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment

Not yet recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 3·NCT05454345·620 enrolled

TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens

Completed·CCenters for Disease Control and Prevention·Phase 3·NCT02410772·2,516 enrolled

TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis

Completed·CCenters for Disease Control and Prevention·Phase 3·NCT00023335·1,000 enrolled

Tuberculosis Prevention for HIV Infected Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00057122·1,148 enrolled

TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Completed·CCenters for Disease Control and Prevention·Phase 2·NCT00023426·150 enrolled

Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

Not yet recruiting·SShandong University·Phase 2·NCT06917495·300 enrolled

Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT07124559·144 enrolled

TBTC Study 31 PK/PD: Population Pharmacokinetic and Pharmacodynamic Study of Efficacy and Safety of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis in the Study 31 Treatment Trial: Intensive PK Sampling

Completed·CCenters for Disease Control and Prevention·Phase 3·NCT02563327·2,516 enrolled

A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB

Not yet recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT07595042·900 enrolled

Shortened Regimen for Drug-susceptible TB in Children

Recruiting·JJohns Hopkins University·Phase 3·NCT06253715·860 enrolled

TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children Receiving Once Weekly Rifapentine and Isoniazid for the Treatment of Latent Tuberculosis Infection

Completed·CCenters for Disease Control and Prevention·Preclinical·NCT00164450·158 enrolled

Interaction3 trials

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients

Completed· Sanofi logo

Sanofi·Phase 1·NCT01690403·25 enrolled

Doravirine, Rifapentine and Isoniazid Interaction

Completed·WWalter K. Kraft·Phase 1·NCT03886701·11 enrolled

PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)

Completed·GGlobal Alliance for TB Drug Development·Phase 1·NCT02216331·32 enrolled

FAP2 trials

TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine

Completed·CCenters for Disease Control and Prevention·N/A·NCT00023387·36 enrolled

Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine

Terminated·JJohns Hopkins University·Phase 1·NCT00460759·15 enrolled

Single Dose1 trial

Evaluating the Pharmacokinetics of High-Dose Rifapentine When Given as a Single Dose or in Divided Doses to Healthy Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01574638·44 enrolled

Women1 trial

Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT02651259·50 enrolled

13 more indications

Prevention1 trial

Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT01404312·3,000 enrolled

Tics1 trial

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

Active, not recruiting·TThe Aurum Institute NPC·Phase 1/2·NCT05122026·252 enrolled

Tenofovir1 trial

Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT03510468·51 enrolled

TED1 trial

The Correlate of Risk Targeted Intervention Study

Unknown status·UUniversity of Cape Town·Phase 2/3·NCT02735590·2,927 enrolled

Mycobacterium Avium Complex1 trial

Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.

Completed·AAnderson Clinical Research·Phase 2·NCT00002192

Adult Subject1 trial

A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects

Withdrawn·YYale University·Phase 4·NCT04551573

Drug Interactions1 trial

Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04272242·37 enrolled

Tuberculosis Infection1 trial

An Open-label, Randomized Controlled Trial of the New One-month Regimen Versus the Current Three-month Regimen for the Treatment of Tuberculosis Infection in Vietnam

Withdrawn·FFreundeskreis Für Internationale Tuberkulosehilfe e.V·Phase 3·NCT06191692

Pulmonary Tuberculosis1 trial

TBTC Study 29: Evaluation of a Rifapentine-containing Regimen for Intensive Phase Treatment of Pulmonary Tuberculosis

Completed·CCenters for Disease Control and Prevention·Phase 2·NCT00694629·334 enrolled

Pediatric HIV Infection1 trial

Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention

Recruiting·BBrigham and Women's Hospital·Phase 1·NCT06281834·25 enrolled

Latent Tuberculosis1 trial

Phase I/II Dose Finding and Safety Study of Rifapentine and Isoniazid in HIV-Infected and HIV-Uninfected Children With Latent Tuberculosis Infection

Completed·CCenters for Disease Control and Prevention·Preclinical·NCT03730181·69 enrolled

HIV1 trial

A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04311502·104 enrolled

Unspecified1 trial

Video Based Directly Observed Therapy for Latent TB

Withdrawn·SSt. Louis University··NCT03783728

Regulatory

FDA Approval Timeline[5]

Jun 22, 1998

PRIFTIN

NDA NDA021024

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Rifapentine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Priftin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rifapentine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rifapentine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021024). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial DNA-Directed RNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

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