Last reviewed 2026-05-27 · How we verify

SYO-1644

Samyang Biopharmaceuticals Corporation · Phase 1 active Small molecule ✓ Verified May 2026

SYO-1644 is a Small molecule drug developed by Samyang Biopharmaceuticals Corporation. It is currently in Phase 1 development. Also known as: SYO-1644 100, 150, 200mg.

SYO-1644 is a small molecule being studied in a clinical trial to compare its pharmacokinetic properties with Nexavar in healthy male volunteers. The study aims to evaluate the pharmacokinetic properties of SYO-1644 tablets in comparison to Nexavar tablets.

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	SYO-1644
Also known as	SYO-1644 100, 150, 200mg
Sponsor	Samyang Biopharmaceuticals Corporation
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers (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:

SYO-1644 CI brief — competitive landscape report
SYO-1644 updates RSS · CI watch RSS
Samyang Biopharmaceuticals Corporation portfolio CI

Frequently asked questions about SYO-1644

What is SYO-1644?

SYO-1644 is a Small molecule drug developed by Samyang Biopharmaceuticals Corporation.

Who makes SYO-1644?

SYO-1644 is developed by Samyang Biopharmaceuticals Corporation (see full Samyang Biopharmaceuticals Corporation pipeline at /company/samyang-biopharmaceuticals-corporation).

Is SYO-1644 also known as anything else?

SYO-1644 is also known as SYO-1644 100, 150, 200mg.

What development phase is SYO-1644 in?

SYO-1644 is in Phase 1.

Manufacturer: Samyang Biopharmaceuticals Corporation — full pipeline
Also known as: SYO-1644 100, 150, 200mg

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