TRK-820

Toray Industries, Inc · Phase 1 active Small molecule

TRK-820 is a Small molecule drug developed by Toray Industries, Inc. It is currently in Phase 1 development. Also known as: Nalfurafine Hydrochloride.

TRK-820 is a small molecule intervention being studied in clinical trials for conditions such as uremic pruritus and chronic kidney disease-associated itch. It is being compared to Nalfurafine hydrochloride, a known κ-opioid receptor agonist used to treat uremic pruritus in Japan.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 1 → approval rate +9.6pp
  Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	TRK-820
Also known as	Nalfurafine Hydrochloride
Sponsor	Toray Industries, Inc
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans (NA)
• Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP (PHASE4)
• Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis (NA)
• Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis (PHASE2)
• A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet (PHASE3)
• Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
• TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus (PHASE1)
• Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• TRK-820 CI brief — competitive landscape report
• TRK-820 updates RSS · CI watch RSS
• Toray Industries, Inc portfolio CI

Frequently asked questions about TRK-820

What is TRK-820?

TRK-820 is a Small molecule drug developed by Toray Industries, Inc.

Who makes TRK-820?

TRK-820 is developed by Toray Industries, Inc (see full Toray Industries, Inc pipeline at /company/toray-industries-inc).

Is TRK-820 also known as anything else?

TRK-820 is also known as Nalfurafine Hydrochloride.

What development phase is TRK-820 in?

TRK-820 is in Phase 1.

Related

• Manufacturer: Toray Industries, Inc — full pipeline
• Also known as: Nalfurafine Hydrochloride