Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tropifexor (LJN452), Tropifexor, triopifexor
LJN452 · 5 trials · 5 indications
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
Number of patients reported with adverse events , serious adverse events and death.
Stool frequency at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined
Stool Form at Baseline, Week 1 (Period 1 \& Period 2), Week 2 (Period 1 \& Period 2), and Week 1 \& 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness.
Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28
Vital signs - Systolic Blood pressure
Vital signs
Vital signs
Electrocardiogram (ECG)
Electrocardiogram (ECG)
Hematology panel for safety laboratory assessments.
The maximum (peak) observed drug concentration after single dose administration (mass x volume-1)
Time to reach the maximum (peak) plasma drug concentration after single dose administration (time)
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration sampling time (mass x time x volume-1)
The area under the concentration-time curve from time zero to infinity (mass x time x volume-1)
The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve
The apparent total body clearance of the drug from plasma (volume x time-1)
The apparent volume of distribution during the terminal phase
| 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 |
| LJN452 followed by placebo | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of LJN452 daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of placebo daily for 14 days. |
| Placebo followed by LJN452 | EXPERIMENTAL | Randomized patients in this arm will receive single oral dose of placebo daily for 14 days. There will be a washout period between 7 to 28 days followed by single oral dose of LJN452 daily for 14 days. |
| LJN452 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| tropifexor AM 200 micrograms and Placebo (PM) | EXPERIMENTAL | Tropifexor 200 μg (AM) and Placebo (PM) once daily each |
| tropifexor PM 200 micrograms and Placebo (AM) | EXPERIMENTAL | Tropifexor 200 μg (PM) and Placebo (AM) once daily each |
| Group 1 - Normal Hepatic Function | OTHER | Normal hepatic function - Control - control group |
| Group 2 - Mild Hepatic Impairment | EXPERIMENTAL | Mild hepatic impairment - Child-Pugh A (Score 5-6) |
| Group 3 - Moderate Hepatic Impairment | EXPERIMENTAL | Moderate hepatic impairment - Child-Pugh B (Score 7-9) |
| Group 4 - Severe Hepatic Impairment | EXPERIMENTAL | Severe hepatic impairment - Child-Pugh C (score 10-15) |
| Name | Type | Description |
|---|---|---|
| Tropifexor (LJN452) | DRUG | Comparison with monotherapy and different combination doses |
| Cenicriviroc (CVC) | DRUG | Comparison with monotherapy and different combination doses |
| LJN452 | DRUG | Capsules containing LJN452 |
| Placebo to LJN452 | DRUG | Capsules containing placebo to LJN452 |
| Part 1: LJN452 | DRUG | LJN452 capsules administered once daily for 28 days |
| Part 1: Placebo | DRUG | Matching placebo capsules administered once daily for 28 days |
| Part 2: LJN452 Dose level 1 | DRUG | LJN452 capsules administered once a day for 12 weeks |
| Part 2: Placebo | DRUG | Matching placebo to LJN452 administered once a day for 12 weeks |
| Part 2: LJN452 Dose level 2 | DRUG | LJN452 |
| triopifexor | DRUG | Tropifexor as a dry blend in hard gelatin capsules for oral administration |
| Placebo | DRUG | Placebo capsules for oral administration |
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 ...
LJN452 is an investigational small molecule developed by Novartis AG (ticker NVS) for gastrointestinal and liver conditions. It has been studied in non-alcoholic fatty liver disease, primary bile acid diarrhea, and primary biliary cholangitis. LJN452 is also known as tropifexor, and it remains in clinical development rather than being an approved medicine.
LJN452 has been studied in three indications: non-alcoholic fatty liver disease, primary bile acid diarrhea, and primary biliary cholangitis. Clinical trials enrolled patients with these conditions, including a Phase 2 study in primary biliary cholangitis and a Phase 2 study in primary bile acid diarrhea. It is investigational and not an approved treatment.
LJN452 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trials evaluating LJN452 in liver and bile acid disorders, including studies in primary biliary cholangitis, primary bile acid diarrhea, and non-alcoholic fatty liver disease.
LJN452 is in Phase 1 development overall, with completed Phase 1 and Phase 2 trials in its studied indications. It is investigational and has not been approved by the FDA. The completed studies include a Phase 1 pharmacokinetic trial in hepatic impairment and Phase 2 trials in primary biliary cholangitis and primary bile acid diarrhea.
LJN452 has been evaluated in completed trials including NCT03681457, a Phase 1 pharmacokinetic study in subjects with hepatic impairment; NCT02713243, a Phase 2 study in primary bile acid diarrhea; and NCT02516605, a Phase 2 study in primary biliary cholangitis. These trials are completed and no active trials are ongoing.
Yes, LJN452 is also known as tropifexor. The names refer to the same investigational small molecule developed by Novartis AG. Trial records list the compound under both designations, including the Phase 2 primary biliary cholangitis study titled with tropifexor (LJN452).