Approval Probability
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TD-9855 · 4 trials · 12 indications
Placebo referred to the Day 1 visit, and the change from placebo referred to the time-matched difference from each TD-9855 dosing day (Days 2 through 5) relative to placebo dosing (Day 1).
Baseline was defined as the pre-dose measurement on Day 1 of Part B.
The Likert Scale is question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA). The question asks participants to rate the severity of their orthostatic hypotension symptoms (dizziness, lightheadedness, feeling faint, or feeling like you might black out) on an 11-point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A higher score indicates a worse outcome. Baseline was defined as the pre-lunch measurement on Day -1.
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.
| Arm | Type | Description |
|---|---|---|
| TD-9855 Part A | EXPERIMENTAL | Subjects will receive placebo and escalating single doses of TD-9855 |
| TD-9855 Part B | EXPERIMENTAL | Subjects will receive a single dose of TD-9855 or placebo. |
| TD-9855 Part C | EXPERIMENTAL | Subjects will receive once daily doses of TD-9855 for up to 5 months as part of an optional outpatient open-label extension arm. |
| TD-9855 Dose 1 | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| TD-9855 Dose 2 | EXPERIMENTAL | - |
| TD-9855 + Fluvoxamine + Caffeine | EXPERIMENTAL | Male smokers will receive TD-9855, fluvoxamine, and caffeine |
| TD-9855 + Itraconazole + Caffeine | EXPERIMENTAL | Male non-smokers will receive TD-9855, itraconazole, and caffeine |
| TD-9855 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TD-9855 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| Fluvoxamine | DRUG | oral tablet, QD |
| Itraconazole | DRUG | oral tablet solution, QD |
| Caffeine | DRUG | oral solution, single dose |
Inclusion Criteria: * Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, or pure autonomic failure, (i.e. neurogenic orthostatic hypotension). * At screening, subject must meet the diagnostic criteria of neurogenic orthostatic hypotension, as dem...
TD-9855 is an investigational small molecule being studied for attention-deficit/hyperactivity disorder (ADHD), neurogenic orthostatic hypotension, and drug-drug interactions. It is being developed by Theravance Biopharma, Inc. (TBPH) and is currently in clinical development, with completed trials in these indications.
TD-9855 is a small molecule being developed by Theravance Biopharma, Inc. (TBPH). The specific molecular target of TD-9855 has not been disclosed in the available clinical trial information. It is being studied for conditions including ADHD and neurogenic orthostatic hypotension.
TD-9855 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company has conducted clinical trials of TD-9855 in the United States for ADHD, neurogenic orthostatic hypotension, and drug-drug interaction studies.
TD-9855 is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not FDA approved and remains in clinical development. Theravance Biopharma, Inc. (TBPH) has completed trials in ADHD, neurogenic orthostatic hypotension, and drug-drug interaction studies.
TD-9855 has completed several clinical trials, including NCT01458340 in ADHD (Phase 2, 295 participants), NCT01924143 a mass balance study (Phase 1, 6 participants), NCT02705755 in neurogenic orthostatic hypotension (Phase 2, 34 participants), and NCT03432793 a drug-drug interaction study (Phase 1, 41 participants). All trials were conducted in the United States.
TD-9855 is the investigational name used by Theravance Biopharma, Inc. (TBPH) for this compound. No alternative names have been disclosed in the clinical trial records. It is being studied for ADHD, neurogenic orthostatic hypotension, and drug-drug interactions.