Dexmedetomidine hydrochloride is under clinical development by Orion and currently in the Phase II 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 Dexmedetomidine hydrochloride’s likelihood of approval (LoA) and phase transition for Cancer Pain took place on 17 Feb 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Dexmedetomidine hydrochloride overview

Dexmedetomidine Hydrochloride (Precedex, Dexdor, Xamdex) is a sedative agent. It is formulated as concentrate solution, injectable solution and powder for solution for intravenous route of administration. Dexmedetomidine Hydrochloride is used for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. It is also indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Dexmedetomidine (DEX-IN, DEX-TD, DEX-SL) is under development as a non-intravenous formulation for the treatment of cancer pain, peri procedural pain and acute pain in adult patients undergoing hallux valgus (Bunion) surgery. It was also under development for the treatment of post operative pain and chronic lower back pain.

Orion overview

Orion develops, manufactures and markets human and veterinary pharmaceuticals, and active pharmaceutical ingredients (APIs). Its products include pharmaceuticals for the treatment of central nervous system disorders, cancer, and respiratory diseases. The company’s pipeline encompasses investigational candidates for the treatment of amyotrophic lateral sclerosis, Parkinson’s disease, chronic obstructive pulmonary disease, and various cancer types. Orion’s client base consists of healthcare service providers and professionals, such as doctors, pharmacies, veterinarians, hospitals, healthcare centers, clinics, and laboratories. The company sells its products in European markets through own sales network and in international markets through several partners and distributors. Orion is headquartered in Espoo, Finland.

Quick View Dexmedetomidine hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Dexmedetomidine hydrochloride
Administration Pathway
  • Intravenous
  • Nasal
  • Sublingual
  • Transdermal
Therapeutic Areas
  • Central Nervous System
Key Developers
Highest Development Stage
  • Marketed

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.