A New Approach to Early Renal Intervention

Randomized, Double-Blind, Placebo-Controlled Study

To evaluate the efficacy and safety of a poly-herbal formulation in participants with:

• Serum Creatinine: 1.3–2.0 mg/dL (≥3 months)
• With or without proteinuria
• Non-dialysis population

Primary Clinical Objectives

• Stabilization of renal function
• Reduction in serum creatinine
• Improvement in eGFR
• Reduction in urine protein parameters
• Enhancement of patient-reported outcomes

Why This Matters

Proof of Concept (PoC)

Initial PoC demonstrates encouraging improvement in renal function parameters.

• Additional patients enrolled under capsule-based therapy aligned with Stage A, KDIGO classification (as per Voisin Consulting Life Sciences roadmap).
• Outcomes in earlier patients have been highly encouraging, including improvements across G-stage parameters.

Capsule Development (IND Pathway)

Capsule formulation development for IND submission is in progress.

• Strong early outcomes observed
• Final validation data expected within 3–4 months
• Gradual transition of PoC patients from powder to capsule formulation underway

Synthetic Molecule Program

Preparatory work for identification and extraction of the corresponding synthetic molecule has been successfully completed by our specialized herbal innovation partner..

Pilot Clinical Study (India)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 4X Poly-Herbal Formulation in Stabilizing Renal Function in Participants with Persistently Elevated Serum Creatinine (1.3–2.0 mg/dL for ≥3 months), With or Without Proteinuria.

Study Sponsorship

Fully sponsored by Clement MedLife Solutions Pvt. Ltd. (funding secured).

IND Manufacturing Partner

A leading global drug manufacturer has been finalized as our drug product manufacturing partner

Raw Material Supply

Advanced discussions completed with a regulatory-grade raw material partner

• Final alignment discussions conducted in Second week of May 2026

Synthetic Development Partners

A premier global laboratory has been selected as our preferred strategic partner

Following a positive response and multiple rounds of detailed technical discussions, the proposed scope of work—including MoA studies, lead validation and optimization, and the IND-enabling preclinical program—has been broadly aligned. The collaboration is progressing toward formalization, with onboarding expected subject to execution of CDA and final contractual agreements.

Global Commercialization Strategy

Initial strategic alignment completed with a global clinical execution partner

• Further engagement planned prior to IND launch

Global Supply & Distribution

Strategic discussions initiated with a global supply chain partner

• Detailed planning to follow ahead of IND activation

Herbal Manufacturing Partner (Developing Markets)

A specialized herbal manufacturing partner has been identified as a potential manufacturing partner for herbal products targeting developing markets, with initial alignment on formulation and scale-up completed. Formal collaboration and quality/regulatory alignment are in progress.

US SPV Formation & Investor Onboarding (Immediate Priority)

The next critical step is the formation of a US-based Special Purpose Vehicle (SPV) under the strategic leadership of our US partner.

Motive of US SPV Formation (Point 14)

US SPV | 2-Year Execution Snapshot : IND filed → IND active → clinical program underway → synthetic pipeline advancing → global positioning established

Year 1: Build & Submit

• US SPV formation + investor onboarding
• FDA strategy finalized (SPV as IND sponsor)
• IND-ready CMC (leading manufacturing & raw material partners)
• Strategic partners onboarded: clinical execution & supply chain partners
• Synthetic program advanced (lead ID + IND-enabling preclinical via global laboratory partner
•    Laboratories)
• Publications + KOL engagement initiate
• → Milestone: IND Submission

Year 2: Activate & Develop

• IND clearance + Phase 1/2 trial initiation
• Clinical execution (global standards)
• Synthetic molecule: optimization + preclinical
• Global visibility: KOLs, conferences, publications, branding
• → Milestone: First patient enrolled

• Synthetic molecule: optimization + preclinical
• Clinical execution (global standards)
• Global visibility: KOLs, conferences, publications, branding
• → Milestone: First patient enrolled