On September 22, U.S. President Donald Trump publicly stated that “the use of acetaminophen (commonly known by the brand Tylenol) during pregnancy may be associated with an increased risk of autism.” His remarks drew significant attention from both the medical community and the investment market, once again putting the safety of acetaminophen under the spotlight.
Dr. Kai-Min Chu, Chairman and CEO of Sinew Pharma (6634), noted that although there is currently no conclusive causal evidence, the toxic metabolite NAPQI, produced when acetaminophen is metabolized in the body, is indeed believed to be associated with liver and kidney injury as well as neuro-oxidative stress. He added that in fetuses whose nervous systems are not yet fully developed, there may be potential risks related to such toxicity.
Dr. Chu emphasized that Sinew’s SafeTynadol (SNP-810) represents a next-generation acetaminophen formulation, designed to significantly reduce the formation of NAPQI while maintaining the same analgesic and antipyretic effects as conventional acetaminophen. According to clinical trial data, even at triple the standard dosage, biomarkers of liver toxicity related to NAPQI (such as APAP-Cys protein adducts) were nearly undetectable, and no liver or kidney toxicity or serious adverse effects were observed.
The key innovation of SafeTynadol lies in its metabolic design: by using a safe enzyme inhibitor to block CYP2E1 and other NAPQI-producing enzymes, the formulation prevents toxic metabolite formation at the source. Dr. Chu pointed out that this technology has been patented in multiple countries and has demonstrated safety in human clinical studies, showing potential to become a new over-the-counter pain relief option suitable for use during pregnancy.
According to the latest U.S. FDA medication guidelines, most non-steroidal anti-inflammatory drugs (NSAIDs)—such as ibuprofen, aspirin, and diclofenac—are not recommended during pregnancy, making acetaminophen one of the few remaining pain relievers available to pregnant women. However, as concerns over acetaminophen’s potential risks intensify, the market demand for safer alternatives is rapidly emerging.
Data from Fortune Business Insights predict that the global pain relief market will exceed US $90 billion by 2032, suggesting substantial commercial potential for new drugs that differentiate themselves through improved safety profiles.
Dr. Chu stated that Sinew will continue to advance SafeTynadol’s international clinical development and licensing collaborations, while strengthening engagement with pharmaceutical distribution channels and obstetric-gynecologic practitioners. The company aims to make this Taiwan-developed new drug the new standard in pregnancy pain relief and pediatric medication, opening up a new growth engine for Sinew Pharma.