Enveda, a clinical-stage biotech pioneering a new generation of small-molecule drugs, has announced that the US FDA has cleared its Investigational New Drug (IND) application for a first-in-class oral therapy for Inflammatory Bowel Disease (IBD).

Following this clearance, Enveda has officially initiated a Phase 1 clinical trial for ENV-6946.

This marks the company’s third asset to enter clinical development, alongside ENV-294 (for atopic dermatitis and asthma) and ENV-308 (for obesity), highlighting the productivity of Enveda’s platform in generating innovative treatments for large patient populations.

IBD affects millions globally and is characterized by high rates of treatment failure, frequent loss of response, and chronic cycles of therapy switching—often leading to hospitalizations, steroid dependence, and in severe cases, colorectal cancer or irreversible surgery.

ENV-6946 is designed as a “multi-biologic in a pill,” targeting multiple pro-inflammatory cytokine pathways—including TNFα, IL-23, and TL1A—that currently require separate injectable biologics. Its first-in-class mechanism and gut-preferred pharmacokinetic profile aim to maximize disease-site efficacy while reducing systemic exposure and safety risks.

“The initiation of our Phase 1 trial for ENV-6946 represents a significant achievement for Enveda, as we now have three distinct first-in-class assets in the clinic,” said Viswa Colluru, Chief Executive Officer of Enveda.

“ENV-6946 perfectly embodies our mission to translate life’s chemistry into better medicines. By delivering the efficacy of multiple biologics in a single, gut-restricted oral pill, we hope to provide patients with IBD a convenient and potent therapy that does not force a tradeoff between efficacy, convenience, and safety.”

The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers, beginning with single-ascending-dose (SAD) regimens and advancing to multiple-ascending-dose (MAD) regimens to determine the optimal dosing strategy for future efficacy trials in Ulcerative Colitis and Crohn’s Disease patients.

“Current treatments for IBD often fall short—many patients fail to respond or lose response over time,” said Jose Trevejo, Chief Medical Officer of Enveda.

“This ceiling on efficacy and high rate of secondary non-response leave a substantial unmet need. ENV-6946 is designed to address this gap by modulating multiple inflammatory pathways and concentrating its activity in the gut, where it’s needed most. We are excited to bring this promising oral therapy into the clinic, where patients are waiting for new approaches that can potentially offer deeper, more durable relief.”