Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ampreloxetine · 3 trials · 4 indications
Score change from baseline on the composite of Questions 1 - 6 of the Orthostatic Hypotension Symptom Assessment (OHSA).
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.
Estimation of Area under the concentration-time curve, from time zero to the last measured time point
Estimation of AUC from time zero extrapolated to infinity
Estimation of maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| Ampreloxetine (Open Label) | ACTIVE_COMPARATOR | Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 12 weeks. |
| Ampreloxetine (Randomized Withdrawal) | PLACEBO_COMPARATOR | After completing the open label, participants are randomized to either ampreloxetine or placebo receiving a single, oral, daily dose of active drug or placebo for a further 8 weeks. |
| Long-Term Extension Period | ACTIVE_COMPARATOR | Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 104 weeks. |
| ampreloxetine | EXPERIMENTAL | Participants randomized to ampreloxetine will receive a single, oral, daily dose of active drug for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to Placebo will receive a single, oral, daily dose of placebo for 4 weeks. |
| Normal Hepatic Function | EXPERIMENTAL | Ampreloxetine Dose A single dose administration to subjects with normal hepatic function |
| Mild Hepatic Function | EXPERIMENTAL | Ampreloxetine Dose A single dose administration to subjects with mild hepatic impairment |
| Moderate Hepatic Function | EXPERIMENTAL | Ampreloxetine Dose A single dose administration to subjects with moderate hepatic impairment |
| Severe Hepatic Function | EXPERIMENTAL | Ampreloxetine Dose A single dose administration to subjects with severe hepatic impairment |
| Name | Type | Description |
|---|---|---|
| Ampreloxetine | DRUG | Oral tablet, QD |
| Placebo | DRUG | Oral tablet, QD |
Inclusion Criteria: * Participant is male or female and at least 30 years old. * Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008). * Participant has a diagnosis of possible or probable M...
Ampreloxetine is an investigational small molecule being developed for symptomatic neurogenic orthostatic hypotension (nOH), a condition of low blood pressure upon standing. It is also being studied in symptomatic neurogenic orthostatic hypertension. The drug is in clinical development and has not been approved by the FDA.
Ampreloxetine is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker TBPH. The company is conducting clinical trials to evaluate the drug for symptomatic neurogenic orthostatic hypotension.
Ampreloxetine is in Phase 3 clinical development for symptomatic neurogenic orthostatic hypotension. It has also completed a Phase 1 study. The drug is investigational and has not received FDA approval.
Ampreloxetine has been studied in several trials. NCT03750552, a completed Phase 3 study, evaluated the drug in 195 participants with symptomatic neurogenic orthostatic hypotension. NCT04200573, a completed Phase 1 study, assessed its pharmacokinetics in 31 participants. NCT05696717, an active Phase 3 trial, is studying the drug in 102 participants with multiple system atrophy.
Yes, Ampreloxetine has received orphan drug designation from the FDA. This designation is granted to drugs intended to treat rare diseases, which can provide certain development incentives.
Yes, Ampreloxetine is also known as TD-9855. Clinical trial records refer to the drug by both names, with TD-9855 appearing in earlier study titles and Ampreloxetine used in later ones.