Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tropifexor · 1 trial · 1 indication
Occurrence of adverse events and serious adverse events Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks
| Arm | Type | Description |
|---|---|---|
| Arm A: Tropifexor (LJN452) - Dose 1 | EXPERIMENTAL | tropifexor 140 mcg, once daily; given orally |
| Arm B: Cenicriviroc (CVC) | EXPERIMENTAL | CVC 150 mg, once daily; given orally |
| Arm C: Tropifexor (LJN452) Dose 1 + CVC | EXPERIMENTAL | tropifexor 140 mcg + CVC 150 mg, once daily; given orally |
| Arm D: Tropifexor Dose 2 + CVC | EXPERIMENTAL | tropifexor 90 mcg + CVC 150 mg, once daily; given orally |
| Name | Type | Description |
|---|---|---|
| Tropifexor (LJN452) | DRUG | Comparison with monotherapy and different combination doses |
| Cenicriviroc (CVC) | DRUG | Comparison with monotherapy and different combination doses |
Inclusion Criteria: Written informed consent Male and female patients 18 years or older (at the time of the screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440 lb) to participate in the study. Able to communicate well with the investigator, to understand and ...
Tropifexor is an investigational small molecule being developed for Non-alcoholic Steatohepatitis (NASH), a metabolic liver condition. It is not approved and remains in clinical development. A Phase 2 trial evaluated its safety, tolerability, and efficacy in adult patients with NASH and liver fibrosis.
Tropifexor is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule for Non-alcoholic Steatohepatitis (NASH) and has not received regulatory approval.
Tropifexor is in Phase 2 clinical development. It is an investigational small molecule for Non-alcoholic Steatohepatitis (NASH) and is not FDA approved. The Phase 2 trial has been completed, and the drug remains under investigation for this metabolic condition.
Tropifexor was studied in a completed Phase 2 trial with the identifier NCT03517540, titled "Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis." The trial enrolled 193 participants across multiple countries, including the United States, Argentina, Belgium, and Canada.
Tropifexor is also known as LJN452, as indicated by the clinical trial title referencing LJN452. The Phase 2 trial NCT03517540 evaluated a combination treatment of LJN452 (Tropifexor) and CVC in adult patients with NASH and liver fibrosis.