Drug Development

Therapeutic Pipeline

Ion channel-targeted non-opioid therapeutic pipeline. Candidates discovered through our RuCIA platform are advancing into global clinical trials.

Discovery
Pre-clinical
IND
Phase 1
Phase 2
Phase 3
Approval
RCI001
US FDA Phase 2 / Korea Phase 2
RCI002
Pre-clinical / IND Prep (CRPS ODD Prep)
RCI003
Discovery
RCI0165
Pre-clinical / PoC
Dry Eye DiseaseUS FDA Phase 2 / Korea Phase 2

RCI001

Target: TRPV1-Rac1 Downstream Modulator

Unlike direct TRPV1 channel antagonists, RCI001 modulates the TRPV1 downstream Rac1/NLRP3 inflammatory cascade — restoring tear film homeostasis and corneal epithelial healing without blocking thermosensation. Differentiated MoA addresses root inflammatory cause, not just symptoms.

Key Details

  • Differentiated MoA: downstream signal modulator (not a direct TRPV1 antagonist)
  • Global development: US FDA Phase 2 + Korea Phase 2 (2026)
  • 0.25% topical ophthalmic solution — non-steroidal, well-tolerated
  • Sjögren's syndrome model: tear secretion increase within 1 week
  • Therapeutic onset within 4 weeks (vs 8-12 weeks for steroid alternatives)
  • Overcomes steroid side effects: no IOP elevation, no redness, no burning
  • Avoids thermosensation blockade common to first-gen TRPV1 antagonists
  • TRPV1 active-disease treatment patents granted in Korea, Japan, US

Milestones

FDA Phase 2 IND Approved (2025.08)
NCT07068958 Registered
Korea Phase 2 Planned (H1 2026)
Hanlim Pharma Licensing (RCI001/RCI001U)
French Veterinary Pharma Co-development (RCI001AH)
Interim Analysis Q1 2026
Non-Opioid Chronic PainPre-clinical / IND Prep (CRPS ODD Prep)

RCI002

Target: TRPV1-MOR Biased Dual Target

MOR biased dual-target non-opioid analgesic simultaneously modulating TRPV1 and MOR — preparing CRPS Orphan Drug Designation

Key Details

  • Indications: CRPS, OA, diabetic neuropathy, CIPN, fibromyalgia
  • MOR biased agonism minimizes addiction/tolerance risk
  • Single dose: 2+ weeks pain reduction in OA model
  • No abnormal fever side effect (solved 1st-gen TRPV1 issue)
  • Efficacy at 650x lower concentration vs existing treatments
  • FDA Orphan Drug Designation (ODD) for CRPS in preparation

Milestones

Pre-clinical Efficacy Studies Complete
Formulation Research (Dr. Dongjin Jang, Gangwon Univ.)
CRPS Orphan Drug Designation (ODD) in Preparation
SfN Conference Presentation (2025.11)
Scale-up TIPS KRW 1.2B Funded (2024)
Global IND Filing Q2 2026
Phase 1 Initiation H2 2026
PsoriasisDiscovery

RCI003

Target: Selective Modulator of Psoriasis Target Proteins

AI drug platform-based selective modulation of psoriasis target proteins — leveraging TRPV1 ion channel expertise

Key Details

  • Syntekabio AI platform (STB) for target protein analysis
  • RudaCure TRPV1 expertise applied to skin disease ion channels
  • Sogang University: compound synthesis & optimization
  • Inje University: candidate compound efficacy evaluation
  • Research period: Apr 2026 – Mar 2028

Milestones

Syntekabio Collabo R&D Phase 2 Selected (2026)
Syntekabio Collabo R&D Selected (2024)
Sogang Univ. & Inje Univ. Consortium
AI Platform (STB) Target Analysis
Candidate Compound Synthesis in Progress
In-vitro/In-vivo Efficacy Evaluation Planned
Veterinary Pain Treatment (Gene Therapy)Pre-clinical / PoC

RCI0165

Target: TRPV1 Only Target (AAV Vector)

AAV vector-based TRPV1-targeted gene therapy — single administration for long-term pain relief in animals

Key Details

  • AAV (Adeno-Associated Virus) vector-based gene therapy
  • TRPV1 ion channel single target (only target)
  • Single administration provides 3+ months sustained pain relief
  • For chronic pain management in companion animals and high-value animals (racehorses)
  • Global veterinary pain treatment market ~$2B annually

Milestones

Private Investment Scale-Up Program Selected (2026.4)
Agri-Food Venture Program Selected (2025)
AAV Vector-based PoC Complete
Single Dose 3+ Month Analgesic Effect Confirmed
Targeting Companion Animals & Racehorses