Drugs / TP05
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | ulcerative colitis | — | “新技術を適用した改良型 メサラジン製剤「TP05」につきましては、潰瘍性大腸炎を対象としてフェーズⅢを終了し、平成29年１月に欧州 において承認申請を実施済みであります。” zeria.co.jp ↗ “新技術を適用した改良型メサラジン製剤「TP05」につきましては、潰瘍性大腸炎を対象としてフェーズⅢを終 了し、平成29年１月に欧州において承認申請を行いました。” zeria.co.jp ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02306798 | Sep → Nov 2013 | ulcerative colitis | Tillotts Pharma AG | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05387083 | Dec 2022 → Jun 2024 | — | Tarsus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01903252 | Jul 2013 → May 2016 | ulcerative colitis | Tillotts Pharma AG | Completed | Met primary |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-01-22 | Tillotts Pharma AG | Tillotts Pharma AG announces launch of ASACOL TM 1600 mg (mesalazine)* for ulcerative colitis tillotts.com ↗ |
| 2017-10-11 | Tillotts Pharma AG | Tillotts Pharma: Positive Results of Largest Phase III Clinical Trial of Mesalazine Induction Therapy Published tillotts.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TP05 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02306798 ↗ |
| Known as | Mesalazine | “TP05 (Mesalazine) 1600mg” NCT01903252 ↗ |
| Route | Oral | “Single Oral Low Dose of TP-05 tablet.” NCT05387083 ↗ |