NCT04670120

Early Bactericidal Activity Safety Pulmonary Tuberculosis Pyrifazimine (TBI-166)

Status unknown Phase 2 Last updated 20 September 2021

What this trial tests

Phase 2 trial testing Pyrifazimine (TBI-166) in Sensitive Pulmonary Tuberculosis in 56 participants. Status unknown.

Timeline

1 March 2021

Primary endpoint
30 June 2021

31 December 2021

Quick facts

Lead sponsor	Beijing Chest Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	1 March 2021
Primary completion	30 June 2021
Estimated completion	31 December 2021
Sites	3 locations across China

Drugs / interventions tested

• Pyrifazimine (TBI-166) — full drug profile →

Conditions studied

• Sensitive Pulmonary Tuberculosis — all drugs for Sensitive Pulmonary Tuberculosis →

Sponsor

Beijing Chest Hospital

Who can join

Adults 18 to 65, any sex, with Sensitive Pulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The new drug pyrifazimine (previous name: TBI-166) developed by the Institute of Materia Medica of the Chinese Academy of Medical Sciences which is Beijing Union Pharmaceutical Second Factory relied on is obtained by retaining the key skeleton of the lead drug clofazimine which can exert its efficacy and modification by introducing moderate polar groups structural. While the drug has strong activity against tuberculosis-sensitive bacteria and drug-resistant bacteria in vivo and in vitro, its pharmacokinetic properties and skin staining side effects have been significantly improved compared with the lead drugs, so that the drug can achieve the goal that reducing fat solubility, accelerating metabolism in the body, reducing skin staining and reducing side effects. In addition, pyrifazimine has a weak effect on liver drug enzymes, and is suitable for combined use in the clinical treatment of tuberculosis. The development of the drug is expected to provide a new method for the clinical treatment of drug-resistant tuberculosis, benefit patients, and produce good social benefits.

In November 2016, the new anti-drug-resistant tuberculosis drug pyrifazimine and its tablets (formerly chemical drug registration classification 1.1) obtained the drug clinical approval issued by the CFDA (batch number: 2016L10025/2016L09987), and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation.

In accordance with relevant requirements of drug registration regulations, technical guidelines, etc., this project has completed the safety, tolerability, and pharmacokinetic clinical trials of a single dose of pyrifazimine tablets in healthy subjects, i.e. Phase Ia clinical trials test.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Analysis of the Clinical Pipeline of Treatments for Drug-Resistant Bacterial Infections: Despite Progress, More Action Is Needed.
   Butler MS, Gigante V, Sati H, Paulin S, et al · · 2022 · cited 165× · PMID 35007139 · DOI 10.1128/aac.01991-21
2. Antibiotics in the clinical pipeline as of December 2022.
   Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
3. Therapeutic developments for tuberculosis and nontuberculous mycobacterial lung disease.
   Dartois V, Dick T. · · 2024 · cited 68× · PMID 38418662 · DOI 10.1038/s41573-024-00897-5
4. Clofazimine for the treatment of tuberculosis.
   Stadler JAM, Maartens G, Meintjes G, Wasserman S. · · 2023 · cited 52× · PMID 36817137 · DOI 10.3389/fphar.2023.1100488
5. A Review of Antibacterial Candidates with New Modes of Action.
   Butler MS, Vollmer W, Goodall ECA, Capon RJ, et al · · 2024 · cited 49× · PMID 39018341 · DOI 10.1021/acsinfecdis.4c00218
6. Antibacterials with Novel Chemical Scaffolds in Clinical Development.
   Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x
7. Revolutionizing tuberculosis treatment: Breakthroughs, challenges, and hope on the horizon.
   Kufa M, Finger V, Kovar O, Soukup O, et al · · 2025 · cited 6× · PMID 40370552 · DOI 10.1016/j.apsb.2025.01.023
8. Current and emerging therapies for pulmonary tuberculosis in adults.
   Mahmood A, Ashfaq MB, Drain C, Melby E, et al · · 2026 · PMID 42046646 · DOI 10.1136/bmjmed-2025-001836