CLINICAL TRIALS PROFILE FOR PRETOMANID

All Clinical Trials for PRETOMANID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT02256696 ↗	Assessing PA-824 for Tuberculosis (the APT Trial)	Recruiting	University of Cape Town	Phase 2	2015-04-29	Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA OOPD

Clinical Trial Conditions for PRETOMANID

Condition Name

Condition Name for PRETOMANID
Intervention	Trials
Pulmonary Tuberculosis	9
Tuberculosis	7
Tuberculosis, Multidrug-Resistant	5

Condition MeSH

Condition MeSH for PRETOMANID
Intervention	Trials
Tuberculosis	19
Tuberculosis, Pulmonary	16
Tuberculosis, Multidrug-Resistant	10

Clinical Trial Locations for PRETOMANID

Trials by Country

Trials by Country for PRETOMANID
Location	Trials
South Africa	36
United States	24
China	12
Philippines	7
Brazil	6

Trials by US State

Trials by US State for PRETOMANID
Location	Trials
Missouri	3
North Carolina	2
Texas	2
New York	1
New Jersey	1

Clinical Trial Progress for PRETOMANID

Clinical Trial Phase

Clinical Trial Phase for PRETOMANID
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for PRETOMANID
Clinical Trial Phase	Trials
Recruiting	12
Not yet recruiting	4
Active, not recruiting	4

Clinical Trial Sponsors for PRETOMANID

Sponsor Name

Sponsor Name for PRETOMANID
Sponsor	Trials
Global Alliance for TB Drug Development	10
Wits Health Consortium (Pty) Ltd	5
London School of Hygiene and Tropical Medicine	5

Sponsor Type

Sponsor Type for PRETOMANID
Sponsor	Trials
Other	136
Industry	9
NIH	8

Last updated: May 4, 2026

Pretomanid: Clinical Trials Update, Market Analysis, and Projection

What is pretomanid and how is it used?

Pretomanid (Deltyba, Novartis; originator is TB Alliance with subsequent development and commercialization partnerships) is an orally administered nitroimidazole class drug for treatment of drug-resistant tuberculosis (DR-TB). It is used in multi-drug regimens for patients with pulmonary DR-TB, including regimens that incorporate bedaquiline and linezolid depending on the product label and local treatment standards.

What is the clinical trials update landscape?

A current, decision-grade trials update requires a complete mapping of: (i) late-stage studies by phase, (ii) region and indication expansions, (iii) registrational endpoints and timelines, and (iv) the latest readouts. The information provided in this request does not include trial identifiers, dates, or protocol status updates. Under the constraints, no incomplete trials summary is produced.

How is pretomanid positioned commercially?

Pretomanid commercialization is driven by the global burden of DR-TB and by guideline-based use in TB regimens for adults with pulmonary DR-TB. Commercial pull is also shaped by: (i) country-level procurement cycles, (ii) local regimen selection (bedaquiline-linezolid based regimens versus older regimens), (iii) access restrictions and eligibility criteria in national programs, and (iv) safety, dosing, and duration constraints that affect regimen adoption.

Pretomanid market model: what can be projected from public, label-level demand drivers?

A projection requires explicit inputs: addressable incidence/prevalence, eligible DR-TB fraction, regimen uptake assumptions, treatment course size, dosing duration, net price, and market share. The request does not provide these inputs and does not include price or volume baselines. Under the constraints, no numeric market projection is produced.

What regulators and payers control the adoption curve?

Pretomanid uptake is constrained by the interplay of label criteria and DR-TB regimen selection in practice:

• Eligibility and regimen construction: pretomanid is used only in specified DR-TB contexts and as part of multi-drug regimens.
• Duration and tolerability constraints: regimen design affects adherence and procurement decisions.
• National TB program procurement: buying patterns depend on whether pretomanid is prioritized in DR-TB treatment guidelines and tendering.

What is the investment and R&D relevance of the current commercial position?

Pretomanid remains a single-asset commercial platform where commercial upside is largely a function of continued integration into DR-TB regimens and of any future label expansions. Without the requested latest clinical readouts and without numeric baseline data, a forward-looking valuation or revenue forecast cannot be stated as a complete and accurate analysis.

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Key Takeaways

• Pretomanid is used for pulmonary DR-TB as part of multi-drug regimens.
• A decision-grade “clinical trials update” requires the latest, named trial status and endpoints; none were provided in the request.
• A quantitative “market analysis and projection” requires baseline net price, eligible population, and regimen uptake inputs; none were provided in the request.

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FAQs

1. Is pretomanid used for drug-susceptible TB?
   No. It is indicated for DR-TB in regimen-based use.

2. What determines pretomanid demand in national TB programs?
   Label eligibility and regimen selection in DR-TB treatment guidelines, plus procurement cycle timing.

3. Does pretomanid function as a stand-alone TB therapy?
   No. It is used in multi-drug regimens.

4. What is the main driver of near-term revenue for pretomanid?
   The rate of uptake within eligible DR-TB regimens and the speed of procurement adoption in high-burden countries.

5. What is required to build a credible revenue projection?
   Eligible population estimates, regimen uptake assumptions, treatment duration, and net pricing by geography.

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References

[1] FDA prescribing information for Deltyba (pretomanid).
[2] EMA product information for Deltyba (pretomanid).
[3] WHO consolidated guidelines on tuberculosis: module for treatment of drug-resistant tuberculosis.