Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-418 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TAK-418 5 mg | EXPERIMENTAL | TAK-418 5 milligram (mg), capsule, orally, once on Day 1. |
| Cohort 2: TAK-418 15 mg | EXPERIMENTAL | TAK-418 15 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed | EXPERIMENTAL | TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohort 4: TAK-418 40 mg | EXPERIMENTAL | TAK-418 40 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohort 5: TAK-418 60 mg | EXPERIMENTAL | TAK-418 60 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohorts 1-5: Placebo | PLACEBO_COMPARATOR | TAK-418 placebo-matching, capsule, orally, once on Day 1. |
| Name | Type | Description |
|---|---|---|
| TAK-418 | DRUG | TAK-418 Capsule. |
| TAK-418 Placebo | DRUG | TAK-418 placebo-matching capsules. |
Inclusion Criteria: 1. Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m\^2) at the Screening Visit. 2. Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months ...
TAK-418 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics after ascending oral single doses. TAK-418 is not approved by the FDA and remains under investigation.
TAK-418 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational small molecule in healthy participants.
TAK-418 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by the FDA and is still in the early stages of clinical testing.
TAK-418 has one completed clinical trial, NCT03228433, titled "A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants." This Phase 1 study enrolled 40 participants in the United States and was placebo-controlled and double-blind.
No, TAK-418 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety, tolerability, and pharmacokinetics in healthy participants, and the drug has not yet progressed to later-stage trials or regulatory approval.