Kapanol is under clinical development by Mayne Pharma Group 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 Kapanol’s likelihood of approval (LoA) and phase transition for Opium (Opioid) Addiction took place on 29 Oct 2021, 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 Kapanol Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Kapanol overview

Morphine sulfate (Kadian, Kapanol, Kapanol LP) is an opioid analgesic agent. It is formulated as sustained release tablets and hard gelatin capsules for oral administration. It is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic are required for an extended period of time. It is also indicated for the relief of chronic pain unresponsive to non-narcotic analgesia and for severe pain associated with cancer.

Morphine sulfate is under development for the treatment of opioid use disorders. It administered through oral route in the form of capsule. It acts by targeting mu type opioid receptor.

Mayne Pharma Group overview

Mayne Pharma Group (Mayne Pharma) formerly HalcyGen Pharmaceuticals, is a specialty pharmaceutical company that manufactures and markets branded and generic medicinal products. The company offers products such as ASTRIX capsules, ERYC capsules, KAPANOL capsules, LOZANOC/TOLSURA capsules, AMETHIA tablets, AMIODARONE HCl tablets, AZURETTE tablets, BUDESONIDE capsules, CAMILA tablets and CLONIDINE transdermal patches among others. It also offers contract development and CDMO services such as pharmaceutical development, analytical testing and commercial manufacturing. The company operates manufacturing facilities in Australia and the US. Mayne Pharma is headquartered in Salisbury South, South Australia, Australia.

Quick View Kapanol LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Kapanol
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Respiratory
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.