Acetaminophen is under clinical development by Angelini 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 Acetaminophen’s likelihood of approval (LoA) and phase transition for Patent Ductus Arteriosus took place on 17 Nov 2021, 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 Acetaminophen Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Acetaminophen overview

Paracetamol (Tachipirina / Tachiverde) is a derivative of acetanilide, acts as analgesic and antipyretic drug. It is formulated as tablet, syrup, granules, effervescent tablets for oral route of administration, injection, solution for intravenous and suppository for rectal route of administration. Paracetamol is indicated for the symptomatic treatment of febrile illness such as influenza, exanthematous diseases, acute diseases of the respiratory tract. It is indicated as analgesic in headaches, neuralgia, muscle pain and other painful (mild to moderate) manifestations of media entity, of various origin (eg, sore headaches, toothaches, stiff neck, joint pain and lumbosacral, menstrual pain, minor surgical procedures).

Paracetamol (Tachipirina / Tachiverde) is also under development for the treatment of patent ductus arteriosus (PDA) in preterm infants. It is administered through intravenous route as solution. The drug candidate acts by targeting COX1 and COX2. 

Angelini overview

Angelini manufactures, markets and distributes pharmaceutical and healthcare products. The company operates in prescription and over-the-counter (OTC) pharmaceutical sectors with a focus on pain and inflammation disorders, infection control and infectious diseases, mental health and central nervous system diseases and disorders. It focuses its research work primarily on the therapeutic areas of traveler’s diarrhea, chronic bacterial prostatitis, major depressive disorder, diabetic neuropathy, pain, inflammation, bacterial infections and others. Angelini is headquartered in Rome, Italy.

Quick View Acetaminophen LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Acetaminophen
Administration Pathway
  • Intravenous
  • Oral
  • Rectal
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Women’s Health
Key Developers
  • Sponsor Company: Angelini
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.