Drugs / ampreloxetine
ampreloxetine
also known as
TD-9855 · Ampreloxetina · AMPRELOXETINE HYDROCHLORIDE · Ampreloxetine monohydrochloride · TD-9855 HCl · TD-9855 MONOHYDROCHLORIDE
Small molecule targets SLC6A2 via inhibition
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04688632 | Jan → Mar 2021 | nanophthalmos 3, orthostatic hypotension | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT04200573 | Jan 2020 → Aug 2021 | orthostatic hypotension | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT03432793 | Feb → Apr 2018 | — | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT01924143 | Oct → Nov 2013 | attention deficit-hyperactivity disorder, fibromyalgia | Theravance Biopharma | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT02705755 | Sep 2017 → Jul 2018 | Parkinson disease, orthostatic hypotension, pure autonomic failure | Theravance Biopharma | Completed | No outcome recorded |
| Phase 2 | NCT01693692 | Nov 2012 → Jan 2014 | fibromyalgia | Theravance Biopharma | Completed | Met primary |
| Phase 2 | NCT01458340 | Dec 2011 → Oct 2013 | attention deficit-hyperactivity disorder | Theravance Biopharma | Completed | Missed primary |
| Phase 33 trials · 2 missed | ||||||
| Phase 3 | NCT04095793 | Sep 2019 → Nov 2021 | orthostatic hypotension | Theravance Biopharma | Terminated | No outcome recorded |
| Phase 3 | NCT03829657 | Feb 2019 → Nov 2021 | Parkinson disease, orthostatic hypotension, pure autonomic failure | Theravance Biopharma | Terminated | Missed primary |
| Phase 3 | NCT03750552 | Jan 2019 → Jul 2021 | orthostatic hypotension | Theravance Biopharma | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT05696717 Comparator | Jun 2023 → Jan 2026 overdue | multiple system atrophy, orthostatic hypotension | Theravance Biopharma | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-03-03 | Theravance Biopharma | Results Theravance Biopharma Reports Phase 3 CYPRESS Study Did Not Meet Primary Endpoint; Board Accelerates Strategic Review and Announces Cost Reduction Actions theravance.com ↗
The study did not meet its primary endpoint in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. |
| 2025-10-29 | Theravance Biopharma | Results Theravance Biopharma to Present Data on Ampreloxetine at the 36th International Symposium on The Autonomic Nervous System theravance.com ↗ |
| 2025-05-09 | Theravance Biopharma | Results Theravance Biopharma Announces Ampreloxetine Presentations at the International MSA Congress theravance.com ↗
Patients with MSA showed clinically meaningful improvement in their nOH symptoms as measured by the OH Symptom Assessment (OHSA) composite score after 16 weeks of open-label treatment with ampreloxetine. |
| 2025-04-07 | Theravance Biopharma | Results Theravance Biopharma Presents Two New Ampreloxetine Analyses in Oral Session at the American Academy of Neurology 2025 Annual Meeting theravance.com ↗
Theravance Biopharma , Inc. (" Theravance Biopharma " or the "Company") (NASDAQ: TBPH) today announced new analyses from its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). |
| 2023-11-16 | Theravance Biopharma | Results Theravance Biopharma to Present New Ampreloxetine Data at the 34th International Symposium on The Autonomic Nervous System theravance.com ↗
The results of this anchor-based analysis of prior ampreloxetine studies underscore the clinical relevance of the Orthostatic Hypotension Symptom Assessment domain of the Orthostatic Hypotension Questionnaire and further substantiate its use as a primary endpoint in clinical studies |
| 2023-08-28 | Theravance Biopharma | Results Theravance Biopharma to Present New Ampreloxetine Data at the 2023 International Congress of Parkinson's Disease and Movement Disorders theravance.com ↗
Ampreloxetine demonstrated the following benefits in MSA (multiple system atrophy) patients from studies 0169 [SEQUOIA] and 0170 [REDWOOD]: |
| 2023-05-09 | Theravance Biopharma | Regulatory Theravance Biopharma, Inc. Announces Orphan Drug Designation Granted to Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy theravance.com ↗
Theravance Biopharma, Inc. (" Theravance Biopharma " or the "Company") (NASDAQ: TBPH) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) status to ampreloxetine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). |
| 2022-11-02 | Theravance Biopharma | Results Ampreloxetine Data in Neurogenic Orthostatic Hypotension to be Presented at the 33rd International Symposium on the Autonomic Nervous System theravance.com ↗
Totality of Evidence from the Phase 3 Clinical Program Demonstrates Ampreloxetine was Effective in Treating Symptoms and Improving Activities of Daily Living in MSA Patients with Neurogenic Orthostatic Hypotension |
| 2022-04-04 | Theravance Biopharma | Results Theravance Biopharma, Inc. Announces Results from Study 0170, a Second Phase 3 Study of Ampreloxetine, in Patients with Symptomatic Neurogenic Orthostatic Hypotension (nOH) theravance.com ↗
The primary endpoint was not statistically significant for the overall population of patients which included patients with Parkinson's disease (PD), pure autonomic failure (PAF) and MSA (odds ratio=0.6; p-value=0.196). |
| 2021-09-15 | Theravance Biopharma | Results Theravance Biopharma, Inc. Announces Top-line Results from a Phase 3 Study of Ampreloxetine in Patients with Symptomatic Neurogenic Orthostatic Hypotension theravance.com ↗
The study did not meet its primary endpoint. |
| 2019-07-22 | Theravance Biopharma | Results Theravance Biopharma Reports New Data from Phase 2 Study of Ampreloxetine (TD-9855) in Oral Presentation at 32nd European Neurology Congress theravance.com ↗
New data demonstrated that patients experienced improvements in their overall nOH symptoms and in their ability to perform daily activities following four weeks of treatment, and that these improvements were sustained until the completion of 20 weeks of ampreloxetine therapy. |
| 2019-06-18 | Theravance Biopharma | Results Theravance Biopharma Reports New Data from Phase 2 Study of Ampreloxetine (TD-9855) in Presentation at 2019 International Association of Parkinsonism and Related Disorders (IAPRD) World Congress theravance.com ↗
New data demonstrated that the study's previously reported improvements in nOH symptom severity following four weeks of treatment were sustained until the completion of 20 weeks of ampreloxetine therapy. |
| 2018-08-01 | Theravance Biopharma | Results Theravance Biopharma Reports Positive Top-Line Four-Week Data from Phase 2 Trial of TD-9855 for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension theravance.com ↗
Top-line results from the study included durable improvements in patients' disease symptom severity after four weeks of treatment with TD-9855, as measured by Orthostatic Hypotension Symptom Assessment Question #1 (OHSA #1). |
All press releases naming this drug 21 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ampreloxetine | “Ampreloxetine, a selective norepinephrine reuptake inhibitor, increases circulating norepinephrine levels.” PMID 34657222 ↗ Oct 2021 |
| Known as | Ampreloxetina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297646 ↗ |
| Known as | AMPRELOXETINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297646 ↗ |
| Known as | Ampreloxetine monohydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297646 ↗ |
| Known as | TD-9855 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03432793 ↗ |
| Known as | TD-9855 HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297646 ↗ |
| Known as | TD-9855 MONOHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297646 ↗ |
| Action | Inhibit | “The findings are consistent with long-lasting NET inhibition, which may increase vasoconstrictor tone, supporting once-daily ampreloxetine dosing in patients with nOH.” PMID 33782836 ↗ Mar 20211“Norepinephrine transporter inhibitor” CHEMBL4297646 ↗ |
| Modality | Small molecule | — CHEMBL4297646 ↗ |
| Route | Oral | “single oral dose” NCT01924143 ↗ |
| Target | SLC6A2 | “Norepinephrine transporter inhibitor” CHEMBL4297646 ↗ |