CLINICAL TRIALS PROFILE FOR PYRAZINAMIDE

505(b)(2) Clinical Trials for pyrazinamide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	AIDS Clinical Trials Group	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.

All Clinical Trials for pyrazinamide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000636 ↗	Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Hoechst Marion Roussel	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Lederle Laboratories	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000796 ↗	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 (MDR	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00000950 ↗	Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.

Clinical Trial Conditions for pyrazinamide

Condition Name

Condition Name for pyrazinamide
Intervention	Trials
Tuberculosis	59
Tuberculosis, Pulmonary	20
Pulmonary Tuberculosis	20
HIV Infections	13

Condition MeSH

Condition MeSH for pyrazinamide
Intervention	Trials
Tuberculosis	124
Tuberculosis, Pulmonary	55
HIV Infections	18
Tuberculosis, Multidrug-Resistant	18

Clinical Trial Locations for pyrazinamide

Trials by Country

Trials by Country for pyrazinamide
Location	Trials
United States	152
China	98
South Africa	64
Brazil	27
Uganda	24

Trials by US State

Trials by US State for pyrazinamide
Location	Trials
New York	13
California	13
Texas	10
Illinois	10
Maryland	9

Clinical Trial Progress for pyrazinamide

Clinical Trial Phase

Clinical Trial Phase for pyrazinamide
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for pyrazinamide
Clinical Trial Phase	Trials
Completed	56
Recruiting	28
Not yet recruiting	19

Clinical Trial Sponsors for pyrazinamide

Sponsor Name

Sponsor Name for pyrazinamide
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	21
Global Alliance for TB Drug Development	11
Beijing Chest Hospital	10

Sponsor Type

Sponsor Type for pyrazinamide
Sponsor	Trials
Other	387
NIH	24
Industry	22

Last updated: July 25, 2026

Pyrazinamide clinical trials update, market analysis and projection (TB drug)

Pyrazinamide remains an off-patent, generic-standard component of multi-drug tuberculosis regimens. There is no single branded, patent-linked “blockbuster” market to project because commercial volume is driven primarily by (1) country TB programs, (2) World Health Organization regimen selection, and (3) generic tender cycles rather than by proprietary exclusivity. Public clinical development activity is concentrated in new combinations, dose strategies, and regimen optimization rather than novel pyrazinamide salts or biologics.

Are there any active clinical trials for pyrazinamide right now?

Featured snippet answer: Pyrazinamide studies currently focus on tuberculosis regimen optimization, including shorter-course strategies, pediatric/PK studies, and combination products rather than stand-alone “new drug” development.

What trial types are most common for pyrazinamide?

1. Dose selection and pharmacokinetics (PK)
   Trials examine exposure targets, effect of rifamycin/isoniazid co-administration, and safety in special populations (children, HIV co-infection, hepatic impairment).
2. Regimen shortening and optimization for drug-susceptible TB
   Studies aim to improve cure rates while reducing total duration, often using standard-of-care backbones with pyrazinamide in the intensive phase.
3. Drug-resistant TB regimen evaluation
   Pyrazinamide is used in certain second-line regimens where susceptibility or regimen design supports it.
4. Operational and adherence-focused trials
   Studies test simplified regimens, sometimes with fixed-dose combination (FDC) approaches.

Where does pyrazinamide appear in trial registries?

Pyrazinamide is typically listed as a comparator arm or as part of an investigational combination regimen under TB protocol titles. Search results in registries usually show pyrazinamide as “pyrazinamide” (plain active) or as part of “combination regimen” study arms.

What is pyrazinamide’s current role in TB treatment guidelines?

Featured snippet answer: Pyrazinamide is used in the intensive phase of standard drug-susceptible TB regimens; its role in drug-resistant disease depends on regimen design and susceptibility.

How do current WHO regimens treat pyrazinamide?

• For drug-susceptible pulmonary TB, pyrazinamide is used to shorten treatment duration when combined with isoniazid and rifampicin (and typically ethambutol in early empiric phases).
• For drug-resistant TB, pyrazinamide is used selectively as part of multi-drug regimens aligned to susceptibility patterns and guideline-defined backbones.

What is the Orange Book status of pyrazinamide products?

Featured snippet answer: Pyrazinamide products are generally not associated with active FDA-listed patent exclusivity through the Orange Book because they are widely available as generics and have long since lost any historical brand-related patent protection.

What does this mean for exclusivity?

• Commercial strategy is not tied to patent-forced pricing power.
• Market entry is typically driven by manufacturing capacity, procurement tenders, and distribution contracts.

How many patents protect pyrazinamide in the US, and how strong is the estate?

Featured snippet answer: Patent coverage for pyrazinamide itself is largely historical and not a practical barrier to generic availability; strength is low for new exclusivity on the core API.

Where patent issues can still matter

Even with an off-patent API, companies can still face IP barriers in these areas:

• Fixed-dose combinations (FDC) if a sponsor controls formulation/process claims for a specific combination ratio and delivery form.
• Manufacturing processes where specific validated steps and impurities are controlled.
• Regimen IP that is not typical for small-molecule TB drugs but can appear in combination claims in certain jurisdictions.

What are the main markets for pyrazinamide sales (by geography and buyer type)?

Featured snippet answer: The largest demand is in high TB-burden countries where government TB programs and global procurement agencies drive bulk ordering of generic TB medicines.

Buyer channel structure

1. National TB programs using centralized procurement
2. Global tenders through multilateral and NGO procurement frameworks
3. Hospital systems in countries with fragmented supply chains
4. Distributor and importers where local manufacturing is limited

Geographic demand drivers

• High-burden regions drive volume: South Asia, sub-Saharan Africa, and parts of Eastern Europe.
• Demand patterns track TB case detection and program funding cycles more than GDP growth.

How big is the pyrazinamide market, and what is the revenue exposure from price versus volume?

Featured snippet answer: The economic exposure is split between low per-unit prices and large volume procurement; pricing pressure is constant because the API is generic and substitution is easy.

Core market mechanics

• Pyrazinamide is purchased as an interchangeable generic API or tablet.
• Revenue is highly sensitive to:
  • tender pricing and exchange rates,
  • freight and import duties,
  • local manufacturing substitution,
  • inventory cycles.

What pricing models dominate?

• Tender-driven price sets the ceiling.
• Batch-lot pricing adjusts to raw material costs.
• Program procurement contracts can lock in volumes for periods, creating short-term revenue predictability.

What is the 2025–2035 market projection for pyrazinamide?

Featured snippet answer: Growth is expected to be modest in unit terms and limited in value terms, with volume supported by TB program continuation and potential regimen shifts that maintain an intensive-phase pyrazinamide component.

Projection logic used for generic TB APIs

1. Baseline demand follows annual TB case burden and treatment coverage.
2. Regimen duration changes can alter pyrazinamide intensity but usually keep it within multi-month TB regimens.
3. Generic substitution keeps price growth low; value CAGR is typically below volume CAGR.
4. Manufacturing expansions in India and China can increase supply, further pressuring price.

Value vs volume outlook

• Volume: likely stable to slightly up as treatment coverage expands or as new cases persist.
• Value: likely flat to low-growth due to tender price compression.

Which companies supply pyrazinamide, and how competitive is the landscape?

Featured snippet answer: Supply is dominated by large generic manufacturers with established TB product lines and regulatory dossiers.

Competitive factors that determine who wins tenders

• Regulatory compliance and inspection outcomes
• Stability of API supply and impurity control
• Capacity planning for bulk procurement timelines
• Ability to meet local pharmacopoeia and labeling requirements
• Distribution coverage and tender responsiveness

Does pyrazinamide face supply constraints or manufacturing risks?

Featured snippet answer: Supply risk exists mainly through raw material availability, capacity constraints in key producer regions, and quality-system failures that can delay batch release.

What typically drives manufacturing disruption

• API raw material shortages
• Inspection findings or recall events
• Quality documentation gaps across batches
• Logistics shocks that hit import-heavy markets

What generic entry risks exist for pyrazinamide tablets?

Featured snippet answer: Barriers are low for the API, but mid-level for specific finished-dose formats that must match national procurement specifications.

Entry risks that matter in practice

• Finished-dose bioequivalence or dissolution requirements (if a jurisdiction mandates them)
• Market-specific registration timelines
• Tender qualification requirements
• Batch release failures and local regulator scrutiny

How does pyrazinamide compare with other TB core drugs in clinical and market dynamics?

Featured snippet answer: Pyrazinamide and rifampicin/isoniazid are “core” in standard regimens, but pyrazinamide has more stability/safety monitoring implications (hepatotoxicity risk) while its market remains highly generic and tender-driven like other TB APIs.

Relative development focus

• Less brand-driven innovation for pyrazinamide.
• More innovation around:
  • shorter regimens (combination strategies),
  • adherence-optimized FDCs,
  • pharmacokinetic tuning in special populations.

What patent litigation affects pyrazinamide or its combination products?

Featured snippet answer: Broad “pyrazinamide-only” litigation is uncommon because the API is generic; litigation risk concentrates in combination formulations or branded FDC products, where formulation and process claims may exist.

Where litigation risk can still show up

• Paragraph IV-style disputes are less relevant for long-established generic APIs unless a specific branded combination still has enforceable patents in a given market.
• Country-specific disputes can occur around:
  • dossier reliance and local registration,
  • formulation/process claims for specific combinations.

What regulatory status does pyrazinamide have for TB programs?

Featured snippet answer: Pyrazinamide is an established TB medicine and is widely approved by national regulators; acceptance is driven by established treatment guidelines and procurement eligibility.

What regulatory milestones typically matter

• National registration/renewal
• Bioequivalence/dissolution proof (where required)
• GMP alignment and batch certification readiness
• Pharmacovigilance obligations in each procurement jurisdiction

Key Takeaways

• Pyrazinamide clinical development centers on TB regimen optimization (PK/dose, shorter-course strategies, combination regimens) rather than new proprietary chemistry.
• The market is generic and tender-driven; exclusivity is not the main determinant of commercial outcomes.
• Market growth is expected to track TB treatment coverage and regimen design that keeps pyrazinamide in intensive-phase components, with value growth constrained by price competition.
• Competitive advantage is mainly manufacturing reliability, quality assurance, regulatory dossier strength, and procurement execution.
• Litigation and regulatory barriers are most relevant for specific finished-dose or FDC combination products, not the core pyrazinamide API.

FAQs

1. What is pyrazinamide used for in tuberculosis treatment?
   It is used primarily in the intensive phase of multi-drug therapy for drug-susceptible TB and selectively in drug-resistant regimens depending on protocol design.

2. Is pyrazinamide available as a generic in most countries?
   Yes. Pyrazinamide is widely manufactured and procured as a generic API and finished-dose tablet where permitted.

3. What are the key safety monitoring issues for pyrazinamide?
   Hepatotoxicity and hyperuricemia-related effects are the primary clinical monitoring focus.

4. Do new pyrazinamide trials seek to shorten TB treatment duration?
   Many studies target regimen optimization that can reduce total treatment duration while maintaining cure rates.

5. How does procurement affect pyrazinamide pricing?
   Pricing is set largely by competitive tenders, batch specifications, and supply-demand cycles, leading to low value growth despite stable or shifting volumes.

References

1. World Health Organization. (n.d.). Tuberculosis treatment guidelines and regimen recommendations. WHO.
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
3. ClinicalTrials.gov. (n.d.). Search results for pyrazinamide in tuberculosis studies. National Library of Medicine.