Company Disclosure

Suven Life Sciences Limited (Scrip Code: 530239, Symbol: SUVEN) submitted a news release to BSE and NSE on June 16, 2026, regarding the completion of Phase-1 clinical studies for its drug candidate SUVN-I6107.

Clinical Study Details

Study Identification: First-in-Human (FIH) Phase-1 clinical study of SUVN-I6107, a Muscarinic M1 Positive Allosteric Modulator (M1-PAM)

Clinical Trial Registry: NCT06705088

Study Design: Two-part, randomized, double-blind, placebo-controlled study in healthy human volunteers

Study Parts:

  • Single Ascending Dose (SAD) segment: 40 participants across five cohorts
  • Multiple Ascending Dose (MAD) segment: 24 participants across three cohorts (14 consecutive days of dosing)

Key Study Findings

Safety Profile: Favorable safety profile with no dose-limiting toxicities. No treatment-related adverse events led to study drug discontinuation or participant withdrawal. No serious adverse events (SAEs) or deaths reported. All treatment-emergent adverse events were mild to moderate in severity and resolved prior to study completion.

Pharmacokinetics: Predictable, dose-proportional pharmacokinetics with exposure (Cmax and AUC) increasing with dose. Median time to peak plasma concentration (Tmax): approximately 2–6 hours. Mean elimination half-life (t½): approximately 7 to 11 hours across evaluated dose range. Achieved projected therapeutic exposures in plasma and at target site.

Demographic Factors: No clinically meaningful differences between male and female participants. Food intake had no clinically relevant impact on pharmacokinetics, supporting flexible dosing regimen.

Pharmacodynamics: Robust pharmacodynamic activity demonstrating evidence of CNS activity. Biomarker assessments showed evidence of increased alertness and enhanced information processing.

Development Status

Based on successful Phase-1 results, SUVN-I6107 is advancing into Phase-2 clinical development for cognitive disorders.

Intellectual Property

Suven Life Sciences owns intellectual property rights for SUVN-I6107 in all major markets.

Company Context

SUVN-I6107 represents the fifth internally discovered candidate (NCE) to enter clinical development for Suven Life Sciences. The company's clinical pipeline includes:

  • Masupirdine (SUVN-502): Global Phase-3 study for agitation in Alzheimer's dementia
  • Samelisant (SUVN-G3031): Phase-2 completed for narcolepsy EDS, Phase-3 ongoing
  • Ropanicant (SUVN-911): Phase-2b study recruitment completed for MDD
  • Usmarapride (SUVN-D4010): Phase-2 study in planning for cognitive disorders
  • SUVN-I6107: Phase-1 completed, advancing to Phase-2 for cognitive disorders

Additional Information

The company stated that detailed findings will be presented in future medical conferences and/or peer-reviewed journal publications.