Drugs / Tropifexor
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04408937 | May → Nov 2020 | liver disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03681457 | Sep 2018 → Sep 2019 | NAFLD1 | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT04147195 | Jun 2020 → Jan 2022 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04065841 | Dec 2019 → Oct 2022 | metabolic dysfunction-associated steatohepatitis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03517540 | Sep 2018 → Sep 2020 | metabolic dysfunction-associated steatohepatitis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02855164 | Aug 2016 → Apr 2020 | metabolic dysfunction-associated steatohepatitis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02713243 | Jan 2016 → Jan 2018 | bile acid malabsorption, primary, 2 | Novartis Pharmaceuticals | Completed | Mixed |
| Phase 2 | NCT02516605 | Sep 2015 → Aug 2018 | primary biliary cholangitis | Novartis Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-11-11 | Novartis Pharmaceuticals | Results Novartis data show tropifexor (LJN452) significantly improves several key biomarkers of NASH in patients with moderate to severe fibrosis novartis.com ↗
This interim analysis showed higher doses of tropifexor (140 Mu g and 200 Mu g) resulted in improvements in several key biomarkers of NASH, including hepatic fat fraction, alanine aminotransferase and body weight, with favorable safety after 12 weeks of treatment. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-11-11 | Novartis Pharmaceuticals | Novartis data show tropifexor (LJN452) significantly improves several key biomarkers of NASH in patients with moderate to severe fibrosis novartis.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tropifexor | “A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of Tropifexor (LJN452) in Subjects With Mild, Moderate or Severe Hepatic...” NCT03681457 ↗5“Tropifexor as a dry blend in hard gelatin capsules for oral administration” NCT04408937 ↗ “Drug: Tropifexor” NCT04147195 ↗ |
| Known as | LJN452 | “Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)” NCT02855164 ↗4“Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy” NCT04065841 ↗ |
| Known as | NVP-LJN452-NXA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298169 ↗ |
| Known as | TXR | “This approach was applied to gain in-depth understanding of fibrosis dynamics after treatment with tropifexor (TXR), a non-bile acid farnesoid X receptor agonist in patients...” PMID 35779659 ↗ Jun 20221“Tropifexor (TXR), a farnesoid X receptor agonist” PMID 31731005 ↗ Nov 2019 |
| Action | Activate | “Bile acid receptor FXR agonist” CHEMBL4298169 ↗1“a non-bile acid FXR agonist” PMID 32702169 ↗ Jul 2020 |
| Modality | Small molecule | — CHEMBL4298169 ↗ |
| Route | Oral | “tropifexor 140 mcg, once daily; given orally” NCT03517540 ↗ |
| Target | NR1H4 | “Bile acid receptor FXR agonist” CHEMBL4298169 ↗ |