Drug Development

Therapeutic Pipeline

Membrane protein-targeted 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
RCI001AH
PoC Complete / Preparing Veterinary Trials
RCI002
Pre-clinical / IND Prep (CRPS ODD Submitted)
RCI003
Discovery
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)
Domestic Co-research with Hanlim Pharma (RCI001/RCI001U)
Interim Analysis Q1 2026
Veterinary Dry Eye (Keratoconjunctivitis Sicca)PoC Complete / Preparing Veterinary Trials

RCI001AH

Target: TRPV1-Rac1 Downstream Modulator

Same mechanism of action as RCI001 — modulates the TRPV1 downstream Rac1/NLRP3 inflammatory cascade. Veterinary formulation targeting dry eye in companion animals (dogs/cats).

Key Details

  • •Same mechanism of action as RCI001 (TRPV1-Rac1/NLRP3 downstream modulation)
  • •Targets dry eye (KCS) in companion animals (dogs/cats)
  • •PoC study complete
  • •Comparative study vs veterinary cyclosporine conducted
  • •Co-development with multinational veterinary pharma, targeting 2030 market entry

Milestones

PoC study complete
Comparative study vs veterinary cyclosporine conducted
Preparing veterinary clinical trials
Co-development with multinational veterinary pharma (targeting 2030 market)
Chronic Pain (Intra-articular)Pre-clinical / IND Prep (CRPS ODD Submitted)

RCI002

Target: MOR Agonist · Intra-articular Delivery

High-potency MOR agonist for intra-articular delivery — local analgesia with minimized systemic exposure. CRPS Orphan Drug Designation submitted

Key Details

  • •Indications: CRPS, OA, diabetic neuropathy, CIPN, fibromyalgia
  • •Intra-articular delivery minimizes systemic exposure
  • •Single dose: 2+ weeks pain reduction in OA model
  • •No body-temperature elevation observed in rodent and marmoset studies
  • •FDA Orphan Drug Designation (ODD) for CRPS submitted

Milestones

Pre-clinical Efficacy Studies Complete
Formulation Research (Dr. Dongjin Jang, Gangwon Univ.)
CRPS Orphan Drug Designation (ODD) Submitted
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
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

Talk to us about the pipeline

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