Last reviewed 2026-06-02 · How we verify

GW117 ODT

Beijing Greatway Pharmaceutical Technology Co.,Ltd. · Phase 1 active Small molecule ✓ Verified Jun 2026

GW117 ODT is a Small molecule drug developed by Beijing Greatway Pharmaceutical Technology Co.,Ltd.. It is currently in Phase 1 development. Also known as: GW117 Orally Disintegrating Tablets.

GW117 ODT is an orally disintegrating tablet used to study the safety and pharmacokinetics in healthy subjects. It is a small molecule binding agent that targets the sphingosine 1-phosphate receptor, and its primary indication is Major Depressive Disorder.

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	GW117 ODT
Also known as	GW117 Orally Disintegrating Tablets
Sponsor	Beijing Greatway Pharmaceutical Technology Co.,Ltd.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects (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:

GW117 ODT CI brief — competitive landscape report
GW117 ODT updates RSS · CI watch RSS
Beijing Greatway Pharmaceutical Technology Co.,Ltd. portfolio CI

Frequently asked questions about GW117 ODT

What is GW117 ODT?

GW117 ODT is a Small molecule drug developed by Beijing Greatway Pharmaceutical Technology Co.,Ltd..

Who makes GW117 ODT?

GW117 ODT is developed by Beijing Greatway Pharmaceutical Technology Co.,Ltd. (see full Beijing Greatway Pharmaceutical Technology Co.,Ltd. pipeline at /company/beijing-greatway-pharmaceutical-technology-co-ltd).

Is GW117 ODT also known as anything else?

GW117 ODT is also known as GW117 Orally Disintegrating Tablets.

What development phase is GW117 ODT in?

GW117 ODT is in Phase 1.

Manufacturer: Beijing Greatway Pharmaceutical Technology Co.,Ltd. — full pipeline
Also known as: GW117 Orally Disintegrating Tablets

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