Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-123 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TAK-123 | EXPERIMENTAL | TAK-123 as 3.75 gram per square meter (g/m\^2) of sodium phenylacetate and 3.75 g/m\^2 of sodium benzoate, intravenous administration over 90 minutes, followed by TAK-123 as 3.75 g/m\^2 of sodium phenylacetate and 3.75 g/m\^2 of sodium benzoate, intravenous administration over 24 hours. |
| Name | Type | Description |
|---|---|---|
| TAK-123 | DRUG | TAK-123 infusion |
Inclusion Criteria: 1. The participant is capable of understanding and complying with protocol requirements in the opinion of the investigator or sub-investigator. 2. The participant signs and dates a written informed consent form prior to the initiation of any study procedures. 3. The participant ...
TAK-123 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The completed Phase 1 trial evaluated its pharmacokinetics, safety, and tolerability after intravenous infusion in Japanese healthy adult male participants.
TAK-123 is being developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. The company conducted a Phase 1 study of the drug in Japan.
TAK-123 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
TAK-123 has one completed Phase 1 trial, NCT04155567, titled 'A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants.' The trial enrolled 10 participants in Japan and was not randomized or blinded.
No, TAK-123 is not FDA approved. It is an investigational small molecule that has completed a Phase 1 trial in healthy volunteers. The drug is still in clinical development and has not been approved for any medical use.