Development Pipeline

From validation to commercialization: a dependency-aware clinical roadmap

Clinical Development Timeline

Q1 2026
Preclinical

Phase 1: Energy Protocol Validation

Finalize NAD+ restoration protocol. Biomarker panel development for ATP, NAD+/NADH ratio, mitochondrial function.

  • NMN dosing optimization (500mg-1g)
  • CoQ10 + Apigenin synergy testing
  • Transition criteria validation
Q2 2026
Phase I Trial

Safety Study: Energy + Clearance

First-in-human trial for E→C transition. 30 participants, 12-week duration. Primary endpoint: safety and biomarker response.

  • Rapamycin 5-10mg weekly safety
  • Autophagy activation markers (LC3-II/I, p62)
  • Energy stability monitoring
Q3 2026
Platform Development

AI State Monitoring System

Deploy personalized monitoring platform. Real-time biomarker tracking, phase transition prediction, adaptive protocol adjustment.

  • Continuous glucose + ketone monitoring
  • Wearable integration (HRV, sleep, activity)
  • ML-driven phase progression recommendations
Q4 2026
Phase I Expansion

Senolytic Timing Study

Validate Phase 3 entry criteria. Compare outcomes with vs without prior autophagy activation. 50 participants, 6-month duration.

  • Dasatinib + Quercetin pulsed protocol
  • Fisetin high-dose validation
  • SASP marker tracking (IL-6, MMP-3, p16)
Q1 2027
Phase II Trial

Full Protocol Validation

E→C→S→R→P complete pathway. 100 participants, 18-month duration. Primary endpoint: epigenetic age reduction.

  • Horvath, GrimAge, PhenoAge clocks
  • Functional capacity measurements
  • Long-term safety monitoring
Q3 2027
Regulatory Strategy

FDA Pathway Initiation

Pre-IND meeting for dependency-gated longevity interventions. Novel category requires regulatory framework development.

  • Endpoints definition for "systemic age reversal"
  • Long-term follow-up protocols
  • Risk-benefit framework for healthy aging
2028
Platform Launch

Clinical Program Rollout

Supervised clinical program for qualified participants. Physician-guided implementation with continuous monitoring.

  • 500+ participant onboarding
  • Real-world evidence collection
  • Protocol refinement from population data

Target Molecules by Phase

Phase 1: Energy

Molecule Mechanism Status
NMN NAD+ precursor Validated
CoQ10 ETC efficiency Validated
Apigenin CD38 inhibitor Testing
PQQ Mitochondrial biogenesis Research

Phase 2: Clearance

Molecule Mechanism Status
Rapamycin mTOR inhibition Validated
Spermidine Autophagy inducer Validated
Urolithin A Mitophagy Testing
Trehalose TFEB activation Research

Phase 3: Senolysis

Molecule Mechanism Status
Dasatinib + Quercetin BCL-2 inhibition Validated
Fisetin Senolytic flavonoid Validated
Navitoclax BCL-2/xL inhibitor Testing
HSP90 inhibitors Stress response Research

Phase 4: Regeneration

Molecule Mechanism Status
Exosomes Paracrine signaling Testing
GDF11 Myostatin family Research
Yamanaka factors Partial reprogramming Research
NAD+ (sustained) Stem cell support Validated

Regulatory Milestones

2026 Q3

Pre-IND Meeting

FDA consultation on novel longevity intervention category

2027 Q1

IND Submission

Investigational New Drug application for Phase II expansion

2028 Q4

Fast Track Designation

Accelerated pathway for age-related disease prevention

Regulatory Strategy

The dependency-gated framework represents a novel intervention category. Unlike traditional single-target drugs, our approach requires regulatory innovation:

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