Last reviewed 2026-04-19 · How we verify

GM-XANTHO onitment

Xantho Biotechnology Co., LTD · Phase 1 active Small molecule

GM-XANTHO onitment is a Small molecule drug developed by Xantho Biotechnology Co., LTD. It is currently in Phase 1 development. Also known as: Drawing blood.

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	GM-XANTHO onitment
Also known as	Drawing blood
Sponsor	Xantho Biotechnology 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

A Phase I/IIa Study to Investigate the GM-XANTHO in Healthy Volunteers and Atopic Dermatitis Patients (PHASE1, PHASE2)

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:

GM-XANTHO onitment CI brief — competitive landscape report
GM-XANTHO onitment updates RSS · CI watch RSS
Xantho Biotechnology Co., LTD portfolio CI

Frequently asked questions about GM-XANTHO onitment

What is GM-XANTHO onitment?

GM-XANTHO onitment is a Small molecule drug developed by Xantho Biotechnology Co., LTD.

Who makes GM-XANTHO onitment?

GM-XANTHO onitment is developed by Xantho Biotechnology Co., LTD (see full Xantho Biotechnology Co., LTD pipeline at /company/xantho-biotechnology-co-ltd).

Is GM-XANTHO onitment also known as anything else?

GM-XANTHO onitment is also known as Drawing blood.

What development phase is GM-XANTHO onitment in?

GM-XANTHO onitment is in Phase 1.

Manufacturer: Xantho Biotechnology Co., LTD — full pipeline
Also known as: Drawing blood

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