Last reviewed 2026-06-03 · How we verify

APL-1401

Jiangsu Yahong Meditech Co., Ltd aka Asieris · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 10/100

APL-1401 is a Small molecule drug developed by Jiangsu Yahong Meditech Co., Ltd aka Asieris. It is currently in Phase 1 development. Also known as: Nepicastat, SYN117.

APL-1401 is a programmed cell death protein 1 inhibitor being studied in a Phase 1b clinical trial for the treatment of moderately to severely active ulcerative colitis. The trial is a randomized, double-blind study comparing the safety and tolerability of APL-1401 to a placebo.

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	APL-1401
Also known as	Nepicastat, SYN117
Sponsor	Jiangsu Yahong Meditech Co., Ltd aka Asieris
Modality	Small molecule
Phase	Phase 1

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis (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:

APL-1401 CI brief — competitive landscape report
APL-1401 updates RSS · CI watch RSS
Jiangsu Yahong Meditech Co., Ltd aka Asieris portfolio CI

Frequently asked questions about APL-1401

What is APL-1401?

APL-1401 is a Small molecule drug developed by Jiangsu Yahong Meditech Co., Ltd aka Asieris.

Who makes APL-1401?

APL-1401 is developed by Jiangsu Yahong Meditech Co., Ltd aka Asieris (see full Jiangsu Yahong Meditech Co., Ltd aka Asieris pipeline at /company/jiangsu-yahong-meditech-co-ltd-aka-asieris).

Is APL-1401 also known as anything else?

APL-1401 is also known as Nepicastat, SYN117.

What development phase is APL-1401 in?

APL-1401 is in Phase 1.

Manufacturer: Jiangsu Yahong Meditech Co., Ltd aka Asieris — full pipeline
Also known as: Nepicastat, SYN117

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