Posted by Michael Wonder on 13 Jan 2026
Sebela Pharmaceuticals announces submission of new drug application to FDA for tegoprazan for the treatment of gastro-oesophageal reflux disease
12 January 2026 - Braintree Laboratories, a part of Sebela Pharmaceuticals, announced that it submitted a new drug application on 9 January 2026 to the US FDA for tegoprazan, a novel potassium-competitive acid blocker, for the treatment of adults with gastro-oesophageal reflux disease.
The new drug application seeks simultaneous approval for three indications: treatment of heartburn associated with non-erosive reflux disease, healing of erosive oesophagitis, and maintenance of erosive oesophagitis healing.
