Last reviewed 2026-05-22 · How we verify

Methosulide

Hubei Biological Medicine Industrial Technology Institute Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

Methosulide is a Small molecule drug developed by Hubei Biological Medicine Industrial Technology Institute Co., Ltd.. It is currently in Phase 1 development. Also known as: CM2010-01.

Methosulide is a compound that has been studied in a clinical trial for its tolerability, safety, and pharmacokinetics in healthy adult subjects. The study, identified as NCT02374684, was a within-group randomized, double-blind, placebo-controlled trial that investigated the effects of methosulide in healthy individuals.

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	Methosulide
Also known as	CM2010-01
Sponsor	Hubei Biological Medicine Industrial Technology Institute 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

Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult 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:

Methosulide CI brief — competitive landscape report
Methosulide updates RSS · CI watch RSS
Hubei Biological Medicine Industrial Technology Institute Co., Ltd. portfolio CI

Frequently asked questions about Methosulide

What is Methosulide?

Methosulide is a Small molecule drug developed by Hubei Biological Medicine Industrial Technology Institute Co., Ltd..

Who makes Methosulide?

Methosulide is developed by Hubei Biological Medicine Industrial Technology Institute Co., Ltd. (see full Hubei Biological Medicine Industrial Technology Institute Co., Ltd. pipeline at /company/hubei-biological-medicine-industrial-technology-institute-co-ltd).

Is Methosulide also known as anything else?

Methosulide is also known as CM2010-01.

What development phase is Methosulide in?

Methosulide is in Phase 1.

Manufacturer: Hubei Biological Medicine Industrial Technology Institute Co., Ltd. — full pipeline
Therapeutic area: All drugs in Other
Also known as: CM2010-01

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