India Pharma Outlook Team | Wednesday, 27 August 2025
Dr. Reddy's Laboratories Ltd. has marked a milestone in the Indian pharmaceutical industry, putting forth Linaclotide, the new first-in-class Guanylate Cyclase-C (GC-C) agonist, in adults with chronic constipation. Under the brand name Colozo, the drug is marketed in 72 mcg and 145 mcg doses, making Dr. Reddy the first company in India to get any regulatory body to sanction Linaclotide.
Already approved by the USFDA, linaclotide is used in adults with chronic idiopathic constipation (CIC), irritable bowel syndrome with constipation (IBS-C), and functional constipation (FC) in the paediatric patient population aged 6 to 17 years. In India, it achieved an indication specifically in the treatment of CIC among adults and is highly selective in a mechanism that targets the guanylate cyclase-C (GC-C) receptors in the intestine.
M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said: “The launch of Colozo marks a significant step in our gastrointestinal segment in India and adds to our list of novel and first-in-class drugs after the launch of BixiBat in India last year. Colozo is a differentiated, USFDA-approved solution for Chronic Constipation. Backed by robust clinical evidence and promising outcomes, Colozo represents a breakthrough in addressing unmet needs of patients and enhancing their quality of life. With Colozo, we continue to strengthen our commitment to deliver advanced therapies that meaningfully improve everyday patient care, in keeping with our goal to serve 1.5 bn patients by 2030.”
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The already USFDA-approved linaclotide is approved to be used to relieve constipation among adults with chronic idiopathic constipation (CIC), irritable bowel syndrome with constipation (IBS-C) and functional constipation (FC) in children aged between 6 to 17 years. The approval will support better therapeutic effects, patient quality of life, and strengthen India's niche in the innovative pharmaceutical therapies.
