Last reviewed 2026-05-22 · How we verify

Singletine

Guangzhou JOYO Pharma Co., Ltd · Phase 1 active Small molecule ✓ Verified May 2026

Singletine is a Small molecule drug developed by Guangzhou JOYO Pharma Co., Ltd. It is currently in Phase 1 development. Also known as: Singletine（DC407）experimental group.

Singletine is a drug being evaluated in a clinical trial (NCT06160401) for its safety, tolerability, pharmacokinetics, and metabolism in healthy adult subjects. The trial is being conducted by Guangzhou JOYO Pharma Co., Ltd to assess the effects of a single dose of Singletine.

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	Singletine
Also known as	Singletine（DC407）experimental group
Sponsor	Guangzhou JOYO Pharma Co., Ltd
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

Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in Adults (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:

Singletine CI brief — competitive landscape report
Singletine updates RSS · CI watch RSS
Guangzhou JOYO Pharma Co., Ltd portfolio CI

Frequently asked questions about Singletine

What is Singletine?

Singletine is a Small molecule drug developed by Guangzhou JOYO Pharma Co., Ltd.

Who makes Singletine?

Singletine is developed by Guangzhou JOYO Pharma Co., Ltd (see full Guangzhou JOYO Pharma Co., Ltd pipeline at /company/guangzhou-joyo-pharma-co-ltd).

Is Singletine also known as anything else?

Singletine is also known as Singletine（DC407）experimental group.

What development phase is Singletine in?

Singletine is in Phase 1.

Manufacturer: Guangzhou JOYO Pharma Co., Ltd — full pipeline
Therapeutic area: All drugs in Other
Also known as: Singletine（DC407）experimental group

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