Drugs / Pretomanid
Pretomanid
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed extensively drug-resistant tuberculosis 1 milestone | |||||
| Filed | EU (EMA) | — | extensively drug-resistant tuberculosis | 2019-08-14 | “In addition to the U.S. FDA, TB Alliance has submitted pretomanid as part of the BPaL regimen for review by the European Medicines Agency” tballiance.org ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | PRETOMANID | — | 2024-11-22 | fda.gov ↗ |
| Approved | EU (EMA) | Dovprela (previously Pretomanid FGK) | — | 2020-07-31 | europa.eu ↗ |
| Approved | US (FDA) | PRETOMANID | — | 2019-08-14 | fda.gov ↗ |
Trials 39
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-11-19 | Global Alliance for TB Drug Development | Results Promising New Data on Pediatric Use of Pretomanid in Children with Drug-Resistant Tuberculosis Presented at 2025 Union Conference tballiance.org ↗
These findings are an important advance toward the goal of making pretomanid-containing regimens available to children. |
| 2025-11-19 | Global Alliance for TB Drug Development | Results Phase 2 Clinical Trial Results Show Potential to Shorten TB Treatment Time tballiance.org ↗
The 100 mg SPaL regimen had greater activity against TB than the standard of care HRZE (isoniazid, rifampin, pyrazinamide, and ethambutol), indicating the potential to shorten treatment time for active TB. |
| 2019-11-13 | Global Alliance for TB Drug Development | Results Results of Phase 2B Clinical Trial Testing New Drug-Resistant TB Treatment Published in Lancet Respiratory Medicine tballiance.org ↗
Results of the Phase 2B trial, known as NC-005 have been published in The Lancet Respiratory Medicine. |
| 2019-08-14 | Global Alliance for TB Drug Development | Regulatory FDA Approves New Treatment for Highly Drug-Resistant Forms of Tuberculosis tballiance.org ↗
Pretomanid, a novel compound developed by the non-profit organization TB Alliance, was approved by the U.S. Food & Drug Administration (FDA) today for treating some of the most drug-resistant forms of tuberculosis (TB). |
| 2019-08-14 | Janssen Research & Development, LLC | Regulatory Statement on U.S. FDA Approval of Pretomanid as Part of Bedaquiline-Containing “BPaL” Regimen jnj.com ↗
the accelerated approval by the U.S. Food & Drug Administration (FDA) of pretomanid—a novel medicine developed by the TB Alliance—as part of a combination regimen |
| 2019-06-06 | Global Alliance for TB Drug Development | Regulatory FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis tballiance.org ↗ |
| 2016-12-16 | Global Alliance for TB Drug Development | Results Clinical Trial of BPaMZ Regimen Will Replace Phase 3 STAND Trial tballiance.org ↗
In light of these results, where the BPaMZ regimen appears to be much more promising compared to the PaMZ (pretomanid + moxifloxacin + pyrazinamide) regimen, the STAND trial testing the PaMZ regimen will not be reopened to new patients. |
| 2016-12-06 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Approval for Clinical Trial on Tuberculosis Drug of Fosun Pharma’s Controlling Subsidiaries fosunpharma.com ↗
Shanghai SunTech Pharmaceutical Co., Ltd. and Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd, its controlling subsidiaries, have received approval from the China Food and Drug Administration in relation to clinical trial |
| 2015-03-18 | Global Alliance for TB Drug Development | Results The Lancet: Results of Phase 2b Trial of Novel TB Regimen PaMZ Show Potential to Shorten, Improve TB Treatment tballiance.org ↗
Nearly twice (71 percent) as many TB patients treated with PaMZ had no TB in their sputum when cultured at the end of the 2-month course of the trial compared to patients treated with standard therapy (38 percent). |
| 2015-01-29 | Global Alliance for TB Drug Development | Results Phase 2a Published Results Show the Potential of a New TB Regimen with Novel Drugs Bedaquiline and Pretomanid (PA-824) tballiance.org ↗
Specifically, the BPaZ regimen killed more than 99 percent of TB bacteria in patient’s sputum in two weeks, and appeared well tolerated and safe. |
| 2012-07-23 | Global Alliance for TB Drug Development | Results Trial Signals Major Milestone in Hunt for New TB Drugs tballiance.org ↗
These results add to a growing body of evidence that the new regimen could reduce treatment by more than a year for some patients. |
All press releases naming this drug 14 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pretomanid | “This two-stage study will compare consented research participants with tuberculous meningitis receiving experimental Bedaquiline (B), Pretomanid (Pa), Linezolid (L);...” NCT07227779 ↗29“The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid,...” NCT05381194 ↗ “Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin...” NCT07209761 ↗ “One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 100 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks” NCT01498419 ↗ “PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment” NCT03896750 ↗ “Pretomanid (PA-824) is a nitroimidazooxazine.” NCT02422524 ↗ “terizidone, pretomanid, linezolid, sutezolid” NCT03237182 ↗ |
| Known as | Dovprela (previously pretomanid fgk) | ChEMBL registry synonym — accepted as the source's own label CHEMBL227875 ↗ |
| Known as | PA-824 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02342886 ↗ |
| Modality | Small molecule | “PA-824 is a novel antituberculosis nitroimidazole in late-phase clinical development.” PMID 24957823 ↗ Jun 2014 |
| Route | Oral | “14 consecutive days of oral administration of PA-824” NCT00567840 ↗ |