Pipeline

SNP-810
Indication

Pain relief and fever reduction (hepatotoxic-free acetaminophen)

Mechanism of Action

Inhibiting liver enzyme activity to prevent the generation of toxic metabolites of acetaminophen known to cause liver damage.

Current Status
  1. Single-dose, low- and high-dose as well as multiple-dose seven-day clinical trials have been completed.
  2. The clinical study testing the dosages exceeding triple recommended label dosage of acetaminophen has completed patient enrollment.
  3. The clinical study in combination with a non-addictive analgesic drug for management of moderate-to-severe pain has completed enrollment of patients undergoing knee replacement.
Product Advantages
  1. There is no competitor for hepatotoxic-free acetaminophen on the market.
  2. Patented innovative combination of safe ingredients to eliminate hepatotoxicity.
  3. Bearing a wider safety margin in which US FDA label of hepatotoxicity warning can be modified or deleted.
  4. Able to seize a significant share of the expansive analgesic market, including NSAIDs, COX-2 inhibitors, and opioids.
Market Potential

According to the Future Market Insights report, the global acetaminophen analgesic market size was approximately US$9.44 billion in 2021, and with CAGR of 4.1%, the global analgesic market in 2031 is expected to reach US$14.07 billion.

Development Progress (as of 2023/12/07)

Clinical trials

  1. Clinical trial of single-dose, low- and high-dose have been completed. The function of SNP-810 effectively reducing the formation of the toxic metabolites of acetaminophen has been verified.
  2. Multi-dose seven-day clinical trial: Total 12 subjects were enrolled, with 6 subjects in each group. The results are in line with the expectations: The high dose can be used continuously for 7 days without any signs of hepatotoxicity, and the study report is under preparation.
  3. SNP-810 besides hepatotoxicity-free data, human bioequivalence study to commercially available Panadol has been performed and validated, proving that clinical efficacy of SNP-810 is equivalent to that of Panadol.
  4. The clinical study testing the dosages exceeding triple recommended label dosage of acetaminophen has completed patient enrollment. This study aims to assess the safety of SNP-810 with oral dosages ranging from 4 to 12 grams per day. Enrollment of 48 people is completed. Data processing, statistical analysis and report preparation are ongoing.
  5. The clinical study in combination with a non-addictive analgesic drug for management of moderate-to-severe pain has completed enrollment of patients undergoing knee replacement. The purpose of development is to verify: (a) SNP-810 has no hepatotoxicity when used in new combination; (b) The combination of non-addictive analgesics can achieve the highest level of pain relief as shown by WHO Analgesic Ladder; (c) Both In- & out-patients can achieve analgesic efficacy by oral administration without using IV injections or nacrotic controlled drugs. Enrollment of 36 patients is completed, and subsequent data processing, statistical analysis and report preparation are ongoing.
  6. For replicating the clinical study testing the dosages exceeding triple recommended label dosage of acetaminophen in the US, the acute GLP toxicology study in rats has been completed in accordance with US FDA requirements, and the acute GLP toxicology study in dogs is ongoing. 

Toxicological studies

  1. Toxicology CROs, such as Charles River Laboratories and QPS, have performed functional tests on mice and proved that SNP-810 is non-hepatotoxic.
  2. Outsource to a foreign toxicology CRO, Charles River Laboratories, to perform acute GLP toxicology study in dogs.

Licensing activities

  1. Company A: The hepatotoxic-free property of SNP-810 has been verified by a third party, and the animal testing results have been provided to Company A.
  2. Company B: Confirmation study is currently underway.
關閉

建議您使用以下瀏覽器觀看本網站,
以獲得最佳瀏覽效果。

要下載瀏覽器,請直接點擊以下: