Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-1211 Dose 1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Elderly | EXPERIMENTAL | TD-1211 Dose 1 |
| Younger | EXPERIMENTAL | TD-1211 Dose 2 |
| Name | Type | Description |
|---|---|---|
| TD-1211 Dose 1 | DRUG | - |
| TD-1211 Dose 2 | DRUG | - |
Inclusion Criteria: * For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive. * Body mass index (BMI) should be 18 to 36 kg/m2, inclusive. * At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supi...
TD-1211 Dose 1 is an investigational small molecule being developed for the treatment of constipation. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential to address constipation, a gastrointestinal condition.
TD-1211 Dose 1 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug for constipation.
TD-1211 Dose 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in early-stage clinical trials to assess its safety, tolerability, and pharmacokinetics in healthy subjects.
TD-1211 Dose 1 has been studied in one completed Phase 1 clinical trial, identified as NCT01655771. This trial, titled 'TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects,' enrolled 47 participants in the United States. The study was controlled but not randomized or double-blinded, and it included healthy volunteers aged 18 years and older.
No, TD-1211 Dose 1 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of constipation. The drug has not completed the clinical trials and regulatory review process required for marketing approval.