Last reviewed 2026-05-24 · How we verify

Xagrotin

Biomad AS · Phase 3 active Small molecule ✓ Verified May 2026 Quality 5/100

Xagrotin is a Small molecule drug developed by Biomad AS. It is currently in Phase 3 development.

Xagrotin is being studied as a treatment for non-severe COVID-19 outpatients in a Phase 3 clinical trial. The trial is being conducted by Biomad AS and also involves the use of green tea as an intervention.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Xagrotin
Sponsor	Biomad AS
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

Diarrhea
Flatulence

Key clinical trials

Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3 (PHASE3)
Treatment of Covid-19 With a Herbal Compound, Xagrotin (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:

Xagrotin CI brief — competitive landscape report
Xagrotin updates RSS · CI watch RSS
Biomad AS portfolio CI

Frequently asked questions about Xagrotin

What is Xagrotin?

Xagrotin is a Small molecule drug developed by Biomad AS.

Who makes Xagrotin?

Xagrotin is developed by Biomad AS (see full Biomad AS pipeline at /company/biomad-as).

What development phase is Xagrotin in?

Xagrotin is in Phase 3.

What are the side effects of Xagrotin?

Common side effects of Xagrotin include Diarrhea, Flatulence.

Manufacturer: Biomad AS — full pipeline
Therapeutic area: All drugs in Other

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