Big Step Forward for VK2735 as FDA Clears Oral Obesity Candidate for Phase 3

Viking Therapeutics US92686J1060

Viking Therapeutics has obtained regulatory clearance to advance VK2735, its oral obesity drug candidate, into late-stage testing. The Phase 3 program is slated to begin in the third quarter of 2026, following the FDA?s confirmation to move ahead. This milestone places Viking among a select group of companies with an oral therapeutic in the final phase of development.

In parallel, work on the injectable version continues apace. The VANQUISH-1 Phase 3 trial has already been fully recruited, and VANQUISH-2 is expected to be completed within this quarter.

Viking is pursuing more than VK2735 alone. The company has fully enrolled a maintenance-dosing study for VK2735, with results anticipated in the third quarter of 2026. Additionally, Viking plans to file an IND during this quarter for a novel Amylin agonist program, representing another potential approach to obesity treatment.

VK2735 is a dual GLP-1/GIP receptor agonist, and its oral formulation could provide a meaningful competitive edge in the market for obesity therapies.

Financial Snapshot

As of the end of 2025, Viking reported cash and equivalents of $706 million. In the fourth quarter, the net loss stood at $157.7 million, while for the full year the losses totaled $358.5 million. R&D expenditures surged in Q4, rising to $153.5 million, reflecting intensified clinical activity.

The forthcoming readouts from the two VANQUISH studies, along with the maintenance-dosing study in the second half of 2026, will indicate whether VK2735 meets market expectations.