The expert panel from the central drug regulatory body has given the green light to Dr. Reddy’s Laboratories for the importation and marketing of their innovative gastrointestinal medication, Tegoprazan, targeted at various digestive disorders.
The submission aimed to gain approval for Tegoprazan tablets, available in both 25 mg and 50 mg doses. Back in 2022, Dr. Reddy’s Laboratories announced a strategic collaboration with South Korea-based HK inn.N Corporation for the distribution and commercialization of their unique patented compound catering to gastrointestinal ailments in India and other key emerging markets.
Dr. Reddy’s presented a detailed proposal seeking permissions to bring in and market Tegoprazan 50 mg and 25 mg tablets. These were backed by pharmacokinetic study data and findings from a comprehensive global Phase III clinical trial that included India as one of the participating countries.
Following thorough discussions, the committee recognized the completion of the Phase III trial and subsequently advocated for the approval of the 50 mg Tegoprazan tablets for conditions like erosive and non-erosive gastroesophageal reflux disease (GERD), and gastric ulcers.
Additionally, the committee endorsed the importation and marketing of 25 mg Tegoprazan tablets to maintain remission of erosive GERD.
However, for its application as an adjunct treatment against Heliobacter pylori infections, a prevalent cause of stomach ulcers, when paired with antibiotics, the firm is required to conduct localized Phase III trials due to global treatment data variability and differing resistance patterns.
Dr. Reddy’s earlier highlighted Tegoprazan as a groundbreaking potassium-competitive acid blocker (P-CAB), a potent selective gastric H+/K+-ATPase inhibitor, offering a new therapeutic avenue for acid-related and motility-linked conditions such as GERD, NERD, various ulcers, and H.pylori eradication, boasting rapid action and sustained gastric pH control.
With the 2022 partnership, the South Korean entity is tasked with manufacturing and supplying Tegoprazan, while Dr. Reddy’s focuses on local clinical development, registration, and commercial operations in the designated territories.
The agreement further entrusts Dr. Reddy’s with exclusive rights to market and distribute Tegoprazan under its brand for a decade post-initial commercial rollout, alongside HK inno.N Corporation receiving upfront licensing fees and potential milestone and royalty earnings upon product sales.