On September 22, the U.S. President Donald Trump publicly stated that “using acetaminophen (commonly known by the brand Tylenol) during pregnancy may be linked to an increased risk of autism.” His remarks have drawn significant attention from both the medical community and investors, once again putting acetaminophen safety in the spotlight.
SINEW PHARMA Chairman Kai-Min Chu noted that, although a clear causal link has not been established, the toxic metabolite NAPQI, produced when acetaminophen is metabolized in the body, is known to be associated with liver and kidney damage as well as oxidative stress in the nervous system. This may pose potential risks, especially when the fetal nervous system is still under development.
Chu emphasized that SafeTynadol (SNP-810), SINEW PHARMA’s next-generation acetaminophen formulation, retains the original analgesic and antipyretic effects while significantly reducing NAPQI production. Clinical trial data show that even at three times the standard dose, NAPQI-related liver toxicity markers (APAP-Cys protein adducts) are nearly undetectable, and no liver or kidney toxicity or severe adverse effects have been observed.
The key innovation of SafeTynadol lies in its mechanism of action: it employs a safety inhibitor to block CYP2E1 and other enzymes responsible for NAPQI formation, preventing the generation of toxic byproducts at the source. Chu added that the technology is patented in multiple countries and has been validated for safety in human clinical trials, positioning it as a promising over-the-counter pain relief option during pregnancy.
According to the latest U.S. FDA guidelines, most non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin, and diclofenac are not recommended for use during pregnancy, making acetaminophen one of the few available pain relief options for expectant mothers. However, with rising concerns over acetaminophen’s potential risks, the demand for safer alternatives is growing rapidly.
Fortune Business Insights predicts that the global analgesics market will exceed $90 billion by 2032, suggesting substantial commercial potential for new drugs that differentiate themselves through enhanced safety.
Chu stated that SINEW PHARMA will continue to advance SafeTynadol through international clinical trials and licensing collaborations, while strengthening integration with pharmaceutical channels and obstetrics-gynecology healthcare providers. The company aims to establish this Taiwan-developed drug as a new standard for pain relief during pregnancy and pediatric use, opening a new growth avenue for SINEW PHARMA.
Resource: 川普引爆乙醯胺酚安全疑慮 欣耀SafeTynadol搶攻孕期止痛新藍海
