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
RC0125 AAV
Drug Optimization
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
CMT2C (Charcot-Marie-Tooth Disease 2C), Skeletal Dysplasia, Scoliosis, Skeletal MalformationsDrug Optimization

RC0125 AAV

Target: TRPV4 Intracellular Target (AAV Vector)

AAV vector-based gene therapy targeting intracellular TRPV4 — developed as an orphan drug with plans to expand to related diseases

Key Details

  • AAV vector-based gene therapy targeting intracellular TRPV4 channel
  • Proven analgesic efficacy in osteoarthritis (OA) animal models
  • Currently undergoing candidate drug optimization
  • Initial development targets rare orphan disease CMT2C, with plans for expansion to related disorders

Milestones

Analgesic efficacy confirmed in OA (Osteoarthritis) models
Validation of intracellular TRPV4 targeting mechanism
Ongoing AAV gene therapy drug optimization
Orphan disease (CMT2C) development with plans to expand to related indications