Ketamine is under clinical development by iX Biopharma and currently in the Phase I and 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 Ketamine’s likelihood of approval (LoA) and phase transition for Complex Regional Pain Syndrome (Sympathetic Reflex Dystrophy/Reflex Sympathetic Dystrophy) took place on 08 Dec 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 Ketamine Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ketamine overview

Ketamine (Wafermine) is under development for the treatment of acute and severe postoperative pain in Hallux valgus (Bunion) and abdominoplasty and also under development for major depressive disorder, post-traumatic stress disorder and treatment resistant depression. It is formulated as a wafer and is administered through sublingual route. It acts by targeting N-methyl-D-aspartate (NMDA) receptor. The drug candidate is developed based on WaferiX sublingual technology.

iX Biopharma overview

iX Biopharma is a pharmaceutical and nutraceutical company. It discover, develops and commercializes novel therapies to treat diseases targeting central nervous system. The company’s products include Wafesil, a sublingual oral wafer containing sildenafil citrate and Silcap, an oral ingestion containing sildenafil citrate for the treatment of male erectile dysfunction. iX Biopharma provides pipeline products such as Wafermine, a sublingual ketamine oral wafer used to manage moderate to severe pain and pioid analgesia, Xativa, a sublingual wafer containing cannabidiol (CBD) against anxiety, movement disorder and chronic inflammation condition. BnoX, a sublingual buprenorphine oral wafer for pain management and Wafernyl, a sublingual fentanyl oral wafer used in breakthrough of cancer pain. iX Biopharma utilizes its proprietary formulation Waferix Sublingual to develop its products. The company conducts its research and development activities in Singapore and Australia. iX Biopharma is headquartered in Singapore.

Quick View Ketamine LOA Data

Report Segments
  • Innovator
Drug Name
  • Ketamine
Administration Pathway
  • Sublingual
Therapeutic Areas
  • Central Nervous System
Key Developers
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.