Approval Probability
TA Base Rate
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TD-0714 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| TD-0714 | EXPERIMENTAL | Capsule formulation |
| Placebo | PLACEBO_COMPARATOR | Capsule formulation |
| Name | Type | Description |
|---|---|---|
| TD-0714 | DRUG | - |
| Placebo | DRUG | - |
| Placebo Comparator | DRUG | One time dosing in capsule formulation |
Inclusion Criteria: * Body Mass Index (BMI) 18 to 32 kg/m2 inclusive * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control * Women of non-childbearing potential are at least 2 years postmenopausal or are s...
TD-0714 is an investigational small molecule being studied in healthy adults and elderly subjects. It is not approved for any disease and remains in early clinical development. The completed Phase 1 trials evaluated the drug in healthy volunteers to assess its safety and tolerability.
TD-0714 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company sponsored the Phase 1 clinical trials of this investigational small molecule.
TD-0714 is in Phase 1 clinical development. Two Phase 1 studies have been completed, including a single ascending dose study and a multiple ascending dose study. The drug is investigational and has not been approved by regulatory authorities.
TD-0714 has completed two Phase 1 trials: NCT02639078, a single ascending dose study in healthy subjects, and NCT02709928, a multiple ascending dose study in healthy and elderly subjects. Both trials were conducted in the United States and enrolled a total of 106 participants.
No, TD-0714 is not FDA approved. It is an investigational drug that has only been studied in Phase 1 clinical trials, which are designed to evaluate safety and tolerability in healthy volunteers. Further clinical development would be required before any approval could be considered.