Roadmap

Clinical Development Pathway

BioBel’s clinical development pathway aligns with TGA and FDA frameworks, integrating patient-centred design and evidence-based methodology.

BioBel’s clinical development programme adheres to the highest international standards, with rigorous protocols designed to demonstrate both efficacy and safety. Our Phase 2 trial design reflects best practices in endocrine clinical research, incorporating patient-centred endpoints and comprehensive safety monitoring.

  • Phase 2 Trial Design

    Randomised, double-blind, placebo-controlled study of postmenopausal women aged 45-65 years. Study design incorporates adaptive elements to optimise dose -finding whilst maintaining statistical rigour.

  • Primary Endpoint

    Reduction in vasomotor symptom frequency and severity as measured by validated patient-reported outcome instruments, with continuous digital tracking to capture real-world symptom patterns.

  • Secondary Endpoints

    Comprehensive assessment of sleep quality, mood stability, metabolic markers, and safety including bone density, cardiovascular biomarkers, and quality of life measures across multiple validated scales.

  • Manufacturing Partnership

    Production via GMP-certified partners in Australia and the European Union, ensuring supply chain redundancy and regulatory compliance across multiple jurisdictions.

  • Trial Initiation

    Q1 2026 – First patient enrolled, with recruitment across multiple sites in Australia and potential expansion to New Zealand and Southeast Asian markets.

Regulatory Strategy: BioBel’s clinical development aligns with both FDA IND and TGA CTN frameworks, positioning the programme for potential multi-market approval pathways including Australia, United States, European Union, and key Asian markets.