Nydrazid

(Isoniazid)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Isoniazid is used to treat tuberculosis (TB), a serious lung infection. It works by killing the bacteria that cause TB or preventing it from spreading.[2] Nydrazid is currently approved and in use across 20 indications[4].[1]

Nydrazid is one of 371 small molecule programs targeting Tuberculosis. It is currently in Approved.

Indications

114

Total Trials

Active Trials

370

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

TuberculosisUnknown status

TicsActive, not recruiting

BurdenActive, not recruiting

OsteomyelitisApproved

ObesityActive, not recruiting

Ulcer DiseaseApproved

HIV InfectionActive, not recruiting

HepatotoxicityActive, not recruiting

Meningeal TuberculosisActive, not recruiting

SilicosisActive, not recruiting

TuberculosisApproved

Unknown status

TicsPhase 2

Active, not recruiting

BurdenPhase 3

Active, not recruiting

OsteomyelitisApproved

Approved

ObesityPreclinical

Active, not recruiting

Ulcer DiseaseApproved

Approved

HIV InfectionApproved

Active, not recruiting

HepatotoxicityPreclinical

Active, not recruiting

Meningeal TuberculosisPreclinical

Active, not recruiting

SilicosisApproved

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

114 2

Maridebart Cafraglutide

Amgen

Phase 3

7 3

Vivia

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Phase 3

1 4

HRS9531

FFujian Shengdi Pharmaceutical Co., Ltd.

Phase 3

1 5

Cagrisema

Novo Nordisk

Phase 3

5 6

Gemtesa

Sumitomo Pharma America, Inc.

Phase 3

1 7

Zenagamtide

Novo Nordisk

Phase 3

3 8

PF-08653944

Pfizer

Phase 3

5 9

Efsubaglutide Alfa

SShanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Phase 3

1 10

Aleniglipron

GGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Pulmonary Tuberculosis

NCT04485156

Q1 2027

Phase 2Active, not recruiting

Tuberculosis, Pulmonary

NCT05556746

Phase 3Active, not recruiting

Multidrug-Resistant Tuberculosis

NCT03568383

Q3 2027

Phase 2Recruiting

ESS

NCT06114628

Phase 2Recruiting

Pulmonary Tuberculosis

NCT06192160

Phase 3Not yet recruiting

Adult

NCT05917340

Clinical

Trials by Indication[1]

Tuberculosis44 trials

Treatment of Latent Tuberculosis Infection With Isoniazid

Completed·IInstituto Nacional de Salud Publica, Mexico·Phase 4·NCT00293228·200 enrolled

Treatment of Latent Tuberculosis in Socially Marginalised Citizens

Terminated·—·Phase 4·NCT03266991·22 enrolled

Randomized Study of Interventions to Enhance Adherence to Isoniazid Prevention Therapy for Tuberculosis in Injection Drug Users

Unknown status·NNational Institute on Drug Abuse (NIDA)·N/A·NCT00004740·300 enrolled

Show 41 more trials

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

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

Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00018083

Rifampin Versus Isoniazid for the Treatment of Latent Tuberculosis Infection in Children (P4v9)

Completed·MMcGill University·Phase 3·NCT00170209·844 enrolled

Efficacy and Safety of Intravenous Treatment of Tuberculosis

Terminated·YYuria-Pharm··NCT04150367·166 enrolled

Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00004736·44 enrolled

Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis

Not yet recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT07129629·45 enrolled

Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

Completed·WWits Health Consortium (Pty) Ltd·Phase 3·NCT04062201·402 enrolled

Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV

Terminated·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group·Phase 2/3·NCT00080119·1,354 enrolled

High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis

Completed·—·Phase 2/3·NCT00513396·134 enrolled

Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis

Withdrawn·IInstituto Nacional de Salud Publica, Mexico·Phase 4·NCT03498534

Assessing PA-824 for Tuberculosis (the APT Trial)

Completed·JJohns Hopkins University·Phase 2·NCT02256696·157 enrolled

The Optimal Duration of Preoperative Anti-tuberculosis Treatment of Spinal Tuberculosis

Unknown status·—·Phase 4·NCT02477852·400 enrolled

REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT01380080·851 enrolled

A Trial of Isoniazid for the Reversion of Interferon Gamma ELISPOT in Tuberculosis (TB) Case Contacts

Completed·MMedical Research Council Unit, The Gambia·N/A·NCT00130325·214 enrolled

A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00317330·6,400 enrolled

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

Completed·IIUATLD, Inc·Phase 3·NCT02409290·588 enrolled

Optimizing Antituberculosis Therapy in Adults With Tuberculous Meningitis

Unknown status·—·N/A·NCT03787940·676 enrolled

Tuberculosis Prevention for HIV Infected Adults

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

Study of Pre-clearance of Latent Tuberculosis Infection And BCG Revaccination

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01119521·82 enrolled

An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

Completed·UUniversity of Cape Town·Phase 2/3·NCT02454205·154 enrolled

Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct

Unknown status·NNational University Hospital, Singapore·Phase 2·NCT04504851·154 enrolled

Addiction, HIV and Tuberculosis in Malaysian Criminal Justice Settings

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

Tuberculosis Treatment Shortening Trial

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00130247·394 enrolled

Isoniazid Plus Antiretroviral Therapy to Prevent Tuberculosis in HIV-infected Persons

Completed·UUniversity of Cape Town·N/A·NCT00463086·1,368 enrolled

Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis

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

Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana

Completed·CCenters for Disease Control and Prevention·Phase 4·NCT00164281·2,000 enrolled

The Treatment of Tuberculosis in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001033·650 enrolled

Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment

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

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Terminated·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01601626·71 enrolled

High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01936831·282 enrolled

Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00816426·19 enrolled

Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)

Completed·OOsaka University·Phase 4·NCT00298870·172 enrolled

Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000950·50 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

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

Not yet recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT07124559·144 enrolled

A Prospective, Randomized Open-Label Phase II Study of the Safety and Tolerability of Metformin in Combination With Standard Antimicrobial Treatment of Pulmonary Tuberculosis in People Co-infected With HIV

Completed·UUniversity of Massachusetts, Worcester·Phase 2·NCT04930744·112 enrolled

Shortened Regimen for Drug-susceptible TB in Children

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

A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis

Recruiting·UUniversity Medical Center Groningen·Phase 1·NCT07708779·8 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

Pulmonary Tuberculosis9 trials

Short-course Regimens for the Treatment of Pulmonary Tuberculosis

Active, not recruiting·CCenters for Disease Control and Prevention·Phase 2/3·NCT05766267·288 enrolled

Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00396084·70 enrolled

A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin for Pulmonary Tuberculosis

Completed·SSt George's, University of London·Phase 3·NCT02581527·672 enrolled

Show 6 more trials

Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)

Not yet recruiting·SSeoul National University Hospital·Phase 3·NCT04485156·926 enrolled

A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000796·525 enrolled

A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000778·44 enrolled

Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia

Completed·UUniversity of Giessen·N/A·NCT02554318·147 enrolled

Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis

Unknown status·—·Phase 4·NCT02901288·3,900 enrolled

A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06192160·315 enrolled

Immunodeficiency4 trials

Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL)

Unknown status·IInstituto Nacional de Salud Publica, Mexico·Phase 4·NCT01875952·100 enrolled

Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000636·2,000 enrolled

Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000959·600 enrolled

Show 1 more trial

Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000638·2,000 enrolled

Tics4 trials

Pharmacogenetics-guided Isoniazid Dosing in TB-HIV

Unknown status·MMakerere University·Phase 2·NCT05124678·40 enrolled

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT02771249·37 enrolled

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

Show 1 more trial

TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB

Completed·CCenters for Disease Control and Prevention·Phase 2/3·NCT00023348·150 enrolled

Treatment3 trials

Treatment of Latent TB Infection for Jailed Persons

Completed·UUniversity of California, San Francisco·Phase 3·NCT00128206·364 enrolled

TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment

Completed·CCenters for Disease Control and Prevention·Phase 2·NCT00164463·72 enrolled

TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment

Completed·CCenters for Disease Control and Prevention·Phase 2·NCT00144417·433 enrolled

41 more indications

Clinical Trial3 trials

Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines

Completed·FFred Hutchinson Cancer Center·Phase 1·NCT05592223·20 enrolled

A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03891901·24 enrolled

Randomized Clinical Trial Comparing 4RIF vs. 9INH for LTBI Treatment-effectiveness

Completed·MMcGill University·Phase 3·NCT00931736·6,031 enrolled

Kidney Transplant2 trials

The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation

Unknown status·WWest China Hospital·N/A·NCT05249699·303 enrolled

Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients

Completed·WWest China Hospital·N/A·NCT06512831·1,348 enrolled

Phase 22 trials

A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Eto Alone and in Combination With BVL-GSK098

Completed·TTASK Applied Science·Phase 2·NCT05473195·105 enrolled

Phase 2a Study of PBTZ169

Terminated·NNearmedic Plus LLC·Phase 2·NCT03334734·16 enrolled

Hepatitis2 trials

NAT2 in Re-challenge of INH in Patients With Hepatitis

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT00728546·100 enrolled

NAT2 Genotyping in Re-challenge Protocol of INH Titration in Patients With Anti-TB Medications-induced Hepatitis

Unknown status·NNational Taiwan University Hospital·N/A·NCT02076685·60 enrolled

Pulmonary TB2 trials

Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design

Completed·MMichael Hoelscher·Phase 2·NCT01785186·365 enrolled

A Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

Completed· Otsuka logo

Otsuka·Phase 2·NCT05221502·122 enrolled

Tuberculosis, Pulmonary2 trials

Multi-centric Prospective Cohort Study of TB Recurrence Free Cure Among Microbiologically Confirmed New Pulmonary Tuberculosis Patients Treated Under NTEP With the 4-month Moxifloxacin Containing Daily Regimen

Completed·TTuberculosis Research Centre, India··NCT05047055·550 enrolled

A Phase IIc, Open-Label, Randomized Controlled Trial of Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis (PRESCIENT)

Active, not recruiting·BBrigham and Women's Hospital·Phase 2·NCT05556746·94 enrolled

Pregnant Women1 trial

Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT01494038·956 enrolled

Metastatic Melanoma1 trial

Phase I Study of Intralesional Bacillus Calmette-Guerin (BCG) Followed by Ipilimumab in Advanced Metastatic Melanoma

Terminated·LLudwig Institute for Cancer Research·Phase 1·NCT01838200·5 enrolled

Drug1 trial

PK Study of Anti-TB Drugs

Completed·UUniversity of Oxford·Phase 1·NCT02457208·61 enrolled

Chronic Inflammation1 trial

Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation

Completed·HHerlev and Gentofte Hospital·Phase 4·NCT04830462·32 enrolled

Adult1 trial

Intensified Short Course Regimen for TBM in Adults

Not yet recruiting·IIndian Council of Medical Research·Phase 3·NCT05917340·372 enrolled

Terminated·UUniversity of Utah·N/A·NCT01550705·11 enrolled

ESS1 trial

Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

Recruiting·UUniversity College, London·Phase 2·NCT06114628·2,500 enrolled

Elderly1 trial

Ultra-Short Regimen for Elderly DS-TB

Not yet recruiting·SShenzhen Third People's Hospital·Phase 3·NCT07076225·300 enrolled

Trial1 trial

A PAN-USR TB Multi-Center Trial

Recruiting·SShenzhen Third People's Hospital·Phase 3·NCT06905522·610 enrolled

Treatment Duration1 trial

Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding (RADIO-TB Trial)

Not yet recruiting·UUniversity College, London·Phase 3·NCT07163143·784 enrolled

Multidrug-Resistant Tuberculosis1 trial

Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT03568383·5,832 enrolled

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

Interaction1 trial

Doravirine, Rifapentine and Isoniazid Interaction

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

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

Alcohol1 trial

Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)

Completed·UUniversity of California, San Francisco·Phase 4·NCT03302299·302 enrolled

Effectiveness1 trial

Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2 (TBL)

Completed·IInstituto Nacional de Salud Publica, Mexico·Phase 4·NCT03278483·396 enrolled

Infection Prevention1 trial

Infant TB Infection Prevention Study

Completed·UUniversity of Washington·Phase 2·NCT02613169·300 enrolled

FAP1 trial

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

ALS1 trial

Evaluation of the Effect of 3HP vs Periodic 3HP vs 6H in HIV-Positive Individuals

Completed·TThe Aurum Institute NPC·Phase 3·NCT02980016·4,027 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Prophylaxis1 trial

Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children

Completed·UUniversity of Cape Town·Phase 3·NCT00330304·450 enrolled

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

Mortality1 trial

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Completed·AAnna Griffiths, MRC·Phase 3·NCT01825031·1,805 enrolled

TED1 trial

The Correlate of Risk Targeted Intervention Study

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

NAC1 trial

PanACEA - STEP2C -01

Recruiting·MMichael Hoelscher·Phase 2·NCT05807399·390 enrolled

Burden1 trial

Implementation for Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals Using Novel Regimen of Isoniazid/Rifapentine Daily (4 Weeks) Compared to Isoniazid/Rifapentine Weekly (12 Weeks)

Active, not recruiting·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 3·NCT03785106·2,500 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

Severe Acute Malnutrition1 trial

Co-SAM: An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated Severe Acute Malnutrition

Completed·QQueen Mary University of London·Phase 3·NCT05994742·674 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

Unspecified3 trials

Isoniazid Dose Adjustment According to NAT2 Genotype (IDANAT2)

Terminated·UUniversity of Cologne·Phase 3·NCT00571753·900 enrolled

Video Based Directly Observed Therapy for Latent TB

Withdrawn·SSt. Louis University··NCT03783728

A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

Completed·SSeoul National University Hospital·N/A·NCT03665402·16 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

NYDRAZID

NDA NDA008662

Jan 1, 1982

RIMIFON

NDA NDA008420

Jan 1, 1982

ISONIAZID

NDA NDA008678

Jan 1, 1982

ISONIAZID

NDA NDA008499

Jan 1, 1982

ISONIAZID

NDA NDA008428

Jan 1, 1982

NYDRAZID

NDA NDA008392

Sources

References

[1]
ClinicalTrials.gov — 114 trial records for Isoniazid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nydrazid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Isoniazid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Isoniazid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA008662). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Enoyl-[acyl-Carrier-Protein] Reductase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Nydrazid

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Tuberculosis44 trials

Pulmonary Tuberculosis9 trials

Immunodeficiency4 trials

Tics4 trials

Treatment3 trials

Clinical Trial3 trials

Kidney Transplant2 trials

Phase 22 trials

Hepatitis2 trials

Pulmonary TB2 trials

Tuberculosis, Pulmonary2 trials

Pregnant Women1 trial

Metastatic Melanoma1 trial

Drug1 trial

Chronic Inflammation1 trial

Adult1 trial

Liver Transplant1 trial

Meningitis1 trial

TIA1 trial

Erythropoietic Protoporphyria1 trial

ESS1 trial

Elderly1 trial

Trial1 trial

Treatment Duration1 trial

Multidrug-Resistant Tuberculosis1 trial

Drug Interactions1 trial

Interaction1 trial

Women1 trial

Tenofovir1 trial

Alcohol1 trial

Effectiveness1 trial

Infection Prevention1 trial

FAP1 trial

ALS1 trial

Pregnancy1 trial

Prophylaxis1 trial

Prevention1 trial

Mortality1 trial

TED1 trial

NAC1 trial

Burden1 trial

Tuberculosis Infection1 trial

Severe Acute Malnutrition1 trial

Latent Tuberculosis1 trial

HIV1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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