Dr. Reddy's Launches Next-Generation Acid Blocker Tegoprazan in India Following Phase III Success
Key Insights
Dr. Reddy's Laboratories has launched tegoprazan, a next-generation potassium-competitive acid blocker (search) (PCAB (search)), in India for treating acid peptic diseases including GERD (search) and gastric ulcers (search).
The drug offers rapid onset of action and sustained gastric pH control, potentially providing significant clinical benefits over existing therapies in acid peptic disease (search) management.
Tegoprazan is already approved in 21 countries including South Korea and China, and has successfully completed Phase III trials in the United States.
Dr. Reddy's Laboratories announced the launch of tegoprazan, a novel patented molecule for acid-related gastrointestinal diseases, in the Indian market. The drug will be marketed under the brand name PCAB (search) in a 50 mg dosage form, marking a significant addition to the company's gastrointestinal therapeutics portfolio.
Novel Mechanism of Action
Tegoprazan represents a next-generation potassium-competitive acid blocker (search) (PCAB (search)) designed to treat acid peptic diseases (APD), including erosive gastro-oesophageal reflux disease (search) (GERD (search)), non-erosive gastro-oesophageal reflux disease (search) (NERD (search)), and gastric ulcers (search). According to Dr. Reddy's, the drug offers a rapid onset of action and sustains elevated gastric pH levels for an extended period, potentially providing significant clinical benefits in the effective management of APD.
The molecule's mechanism differs from traditional proton pump inhibitors, offering sustained gastric pH control that may provide clinical advantages over existing therapies in acid peptic disease (search) management.
Global Approval Status and Clinical Development
Tegoprazan has achieved regulatory approval in 21 countries, including South Korea and China, and is currently undergoing registration in several other markets. The company highlighted that the molecule has successfully completed a Phase III trial in the United States, demonstrating its clinical efficacy and safety profile.
Strategic Partnership
The launch follows an exclusive partnership formed in 2022 between Dr. Reddy's and South Korea-based HK inno.N Corporation to commercialise tegoprazan in India and select emerging markets. This collaboration brings together complementary strengths to enhance patient access to the innovative molecule.
"We are happy to launch Tegoprazan (PCAB (search)®) in India, reinforcing our commitment to innovation in gastrointestinal diseases treatment – a key focus area for us," said M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy's. "Our partnership with HK inno.N Corporation for Tegoprazan brings together complementary strengths to enhance patient access to an innovative molecule that addresses critical gaps in acid peptic disease (search) management and improves outcomes."
HK inno.N Corporation CEO Dal-Won Kwak stated that with the launch of tegoprazan in India, the company aims to establish it as a leading innovative therapy in the potassium-competitive acid blocker (search) (PCAB (search)) class, providing a valuable new treatment option to enhance gastrointestinal care in the country.
Market Position
Dr. Reddy's already maintains a strong portfolio in gastrointestinal therapeutics with established brands such as Omez®, Razo® and Vono™. The addition of tegoprazan further strengthens the company's presence in this therapeutic segment, addressing critical gaps in acid peptic disease (search) management.
The launch announcement came after market hours on Tuesday, with Dr. Reddy's shares having settled 0.79% higher at ₹1,311.10 on the National Stock Exchange (NSE) during regular trading.