Drugs / para-aminosalicylic acid
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Granupas (previously Para-aminosalicylic acid Lucane) | — | 2025-12-04 | europa.eu ↗ |
| Approved | EU (EMA) | Granupas (previously Para-aminosalicylic acid Lucane) | — | 2014-04-07 | europa.eu ↗ |
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03070405 | Oct 2016 → Mar 2017 | — | Inje University | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03237182 | Jun 2017 → Dec 2022 | multidrug-resistant tuberculosis | Centre for the AIDS Programme of Research in South Africa | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02365623 Background | Feb 2015 → Nov 2018 | multidrug-resistant tuberculosis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06081361 Comparator | Dec 2023 → Oct 2026 expected | pulmonary tuberculosis, rifampicin-resistant tuberculosis | Beijing Chest Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02975570 Comparator | Aug 2017 → Aug 2021 | multidrug-resistant tuberculosis | Boston University | Withdrawn | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | para-aminosalicylic acid | “anti-bacterial tuberculosis drugs (pyrazinamide [PZA], ethambutol [EB, EMB], streptomycin [SM], kanamycin [KM, KAN], enviomycin [EVM], ethionamide [TH], cycloserine [CS],...” NCT02365623 ↗4“either cycloserine or para-aminosalicylic acid, with preference for cycloserine” NCT02975570 ↗ “delaminid, para-aminosalicylic acid, imipenem/cilastatin” NCT03237182 ↗ |
| Known as | PAS | “para-aminosalicylic acid [PAS]” NCT02365623 ↗ |
| Route | Oral | “Twice daily oral administration from the first day of each period to the seventh dose” NCT03070405 ↗ |