Ampreloxetine hydrochloride is under clinical development by Theravance Biopharma and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ampreloxetine hydrochloride’s likelihood of approval (LoA) and phase transition for Orthostatic Hypotension took place on 01 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ampreloxetine hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ampreloxetine hydrochloride overview

Ampreloxetine HCL (TD-9855) was under development for the treatment of multiple system atrophy (MSA) patients suffering with neurogenic orthostatic hypotension (NOH), attention deficit hyperactivity disorder (ADHD) and fibromyalgia. The drug candidate is administered orally as a tablet and is a new molecular entity. It acts by targeting serotonin and norepinephrine reuptake.

Theravance Biopharma overview

Theravance Biopharma is a biopharmaceutical company that discovers, develops, and markets organ-selective medicines for the treatment of inflammation and immune system disorders and specializes in developing respiratory medicines. The company is investigating its pipeline candidates for the treatment of asthma; neurogenic orthostatic hypotension (nOH); gastrointestinal motility disorders; ulcerative colitis; heart failure; chronic kidney disease (CKD); Crohn’s disease; gastroparesis and concurrent bacteremia. Theravance Biopharma has agreements with other pharmaceutical companies and holds economic interests in potential future payments made to Innoviva, Inc from Glaxo Group Limited or one of its affiliates. The company has subsidiaries in the US, Ireland and the UK. Theravance Biopharma is headquartered in San Francisco, California, the US.

Quick View Ampreloxetine hydrochloride LOA Data

Report Segments
  • Innovator
Drug Name
  • Ampreloxetine hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.