Diclofenac is under clinical development by Benuvia Therapeutics 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 Diclofenac’s likelihood of approval (LoA) and phase transition for Pain took place on 11 Mar 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Diclofenac overview

Diclofenac is under development for the treatment of pain. It is administered through sublingual route. The drug candidate is a non-steroidal anti-inflammatory drug (NSAID. Diclofenac inhibits the enzyme cyclooxygenase (COX-1 and COX-2). The drug candidate is developed based on spray technology platform. This technology delivers drug product directly to the sub lingual mucosa for rapid and efficient absorption into the bloodstream.

It was also under development for the treatment of inflammation.

Benuvia Therapeutics overview

Benuvia Therapeutics develops and commercializes therapies to treat rare diseases. The company offers SYNDROS, an oral solution that improves nausea and vomiting caused by anti-cancer medicine; loss of appetite in adults with AIDS (acquired immune deficiency syndrome). It is investigating drugs for pains, migraine, erectile dysfunction, nausea and vomiting associated with chemotherapy, psychotic and anxiety disorders, schizophrenia, major depressive disorders and other diseases. The company operates a manufacturing facility in Round Rock, Texas, the US. Benuvia Therapeutics is headquartered in Chandler, Arizona, the US.

Quick View Diclofenac LOA Data

Report Segments
  • Innovator
Drug Name
  • Diclofenac
Administration Pathway
  • Sublingual
Therapeutic Areas
  • Central Nervous System
  • Immunology
Key Developers
  • Sponsor Company: Benuvia Therapeutics
Highest Development Stage
  • Phase II


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.