Industrializing the Selection of Value-Added Medicines
Arenyx Pharma leverages a deterministic AI engine to eliminate the intuition-gap in drug development, identifying high-probability 505(b)(2) and Hybrid pathways.
About ARENYXPHARMA
Transforming pharmaceutical development through deterministic AI
Mission
To industrialize the selection of high-value pharmaceutical development pathways, eliminating guesswork and accelerating the delivery of critical medicines to patients.
Vision
A future where every drug development decision is data-driven, risk-optimized, and capital-efficient—powered by deterministic AI that removes the intuition gap.
Approach
We combine regulatory science, real-world evidence, and proprietary AI algorithms to identify 505(b)(2) and Hybrid pathways with the highest probability of approval and commercial success.
Deterministic AI Technology
Evidence-based intelligence for pharmaceutical development
Data Aggregation
Comprehensive collection of regulatory, clinical, and market data from FDA databases, clinical trial registries, and real-world evidence sources.
Pathway Analysis
Deterministic evaluation of 505(b)(2) and Hybrid regulatory pathways, identifying approvability gaps and clinical development requirements.
Risk Scoring
Quantitative assessment of technical, regulatory, and commercial risks using validated algorithms and historical precedent analysis.
Value Optimization
ROI modeling and portfolio optimization to maximize capital efficiency and strategic value across the development pipeline.
Development Pipeline
High-probability 505(b)(2) and Hybrid programs
ARX01
Once Daily XR Formulation
Indication
Neuropathic pain / depression
Rationale
Smoother PK profile vs. IR
Differentiation
✓ Formulation IP
Regulatory Path
US 505(b)(2) / EU Hybrid
ARX02
Solid Oral Conversion
Concept
Bioequivalent oral solid conversion
Rationale
Accelerates patient discharge
Differentiation
✓ Use Setting + Form
Regulatory Path
PK Bridge Strategy
ARX03
Site-Specific Delivery
Concept
Systemic to localized reformulation
Rationale
Avoid systemic adverse events
Differentiation
✓ Formulation Barrier
Regulatory Path
Local PK / BE
Investor Value Proposition
De-risked pharmaceutical development with superior capital efficiency
Reduced Development Risk
Leveraging established safety data and regulatory precedent to minimize clinical trial uncertainty and accelerate approval timelines.
Capital Efficiency
505(b)(2) pathways require 40-60% less capital than traditional NDA routes, enabling faster ROI and reduced dilution for investors.
Accelerated Timelines
Deterministic pathway selection and streamlined clinical development compress time-to-market by 3-5 years versus traditional approaches.
Strategic Optionality
Portfolio approach with multiple high-probability assets creates diversified value and attractive exit opportunities at multiple inflection points.
Get In Touch
Connect with our team to learn more about our technology and pipeline