Last reviewed 2026-05-27 · How we verify

Repinatrabit

Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1 active Small molecule ✓ Verified May 2026

Repinatrabit is a Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 1 development. Also known as: JNT517.

Repinatrabit is a medication that has been studied in a clinical trial involving healthy volunteers, examining its interaction with other medications such as ethinyl estradiol/norethindrone and metformin. The purpose of this trial was to investigate how repinatrabit interacts with multiple medications when administered together.

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	Repinatrabit
Also known as	JNT517
Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)

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:

Repinatrabit CI brief — competitive landscape report
Repinatrabit updates RSS · CI watch RSS
Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI

Frequently asked questions about Repinatrabit

What is Repinatrabit?

Repinatrabit is a Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who makes Repinatrabit?

Repinatrabit is developed by Otsuka Pharmaceutical Development & Commercialization, Inc. (see full Otsuka Pharmaceutical Development & Commercialization, Inc. pipeline at /company/otsuka-pharmaceutical-development-commercialization-inc).

Is Repinatrabit also known as anything else?

Repinatrabit is also known as JNT517.

What development phase is Repinatrabit in?

Repinatrabit is in Phase 1.

Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
Therapeutic area: All drugs in Other
Also known as: JNT517

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing