Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-625 · 2 trials · 2 indications
Change in fasting sBA levels from Week 18 to 22 was reported. Change was calculated as: observed value at Week 22- observed value at Week 18.
The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Average baseline morning ItchRO (Obs) scores were calculated as sum of the morning scores divided by number of morning scores for the 4-week (28 days) time periods (that is \[i.e.\], Day -28 to Day -1). Average morning ItchRO (Obs) scores Week 15 through Week 26 were calculated as the sum of the morning scores divided by the number of morning scores from Week 15 to Week 26. Change was calculated as: Average value of Weeks 15 to 26 - Average value of Baseline (Day -28 to Day -1).
| Arm | Type | Description |
|---|---|---|
| TAK-625 | EXPERIMENTAL | TAK-625 200 mcg per kilogram, orally, once daily for 1 week. After that, TAK-625 400 mcg per kilogram, orally, once daily after Week 1. |
| TAK-625, Primary cohort | EXPERIMENTAL | TAK-625 orally, twice daily (BID) for 4 weeks as Dose Escalation Period. The dose in Dose Escalation Period will be increased weekly, 150 mcg/kilograms (kg), 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg. After Dose Escalation Period, TAK-625 600 mcg/kg (or maximum tolerated dose \[MTD\]), orally, BID up to study completion. |
| TAK-625, Supplemental cohort | EXPERIMENTAL | TAK-625 orally, twice daily (BID) for 4 weeks as Dose Escalation Period. The dose in Dose Escalation Period will be increased weekly, 150 mcg/kilograms (kg), 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg. After Dose Escalation Period, TAK-625 600 mcg/kg (or maximum tolerated dose \[MTD\]), orally, BID up to study completion. |
| Name | Type | Description |
|---|---|---|
| TAK-625 | DRUG | TAK-625 200 mcg or 400 mcg per kilogram, orally, once daily |
Inclusion Criteria: 1. The participant is Japanese male or female with a body weight \>=3.0 kilograms (kg) and who is \>=1 month of age at the time of informed consent. 2. The participant is diagnosed with ALGS. 3. The participant has one or more of the following evidences of cholestasis: 1. To...
TAK-625 is an investigational small molecule being developed for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS), both rare liver diseases. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
TAK-625 is being developed by Takeda Pharmaceutical Company Limited, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol TAK. The drug is in Phase 3 clinical trials for rare cholestatic liver diseases.
TAK-625 is in Phase 3 clinical development for Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). It is an investigational drug, meaning it has not been approved by regulatory agencies and remains under study in clinical trials.
TAK-625 has completed two Phase 3 trials in Japan: NCT05543174 for Alagille Syndrome (ALGS) with 7 participants, and NCT05543187 for Progressive Familial Intrahepatic Cholestasis (PFIC) with 5 participants. Both trials enrolled patients aged 1 month and older.
The specific molecular target of TAK-625 has not been disclosed in available clinical trial information. It is classified as a small molecule therapeutic being investigated for the treatment of cholestatic liver diseases, but its precise mechanism of action is not publicly detailed.