Last reviewed 2026-04-19 · How we verify

Magnesiun

Federal University of São Paulo · Phase 1 active Small molecule

Magnesiun is a Small molecule drug developed by Federal University of São Paulo. It is currently in Phase 1 development. Also known as: NMDA receptor antagonist.

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	Magnesiun
Also known as	NMDA receptor antagonist
Sponsor	Federal University of São Paulo
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

Magnesium Associated With Morphine for Cancer Pain Relief (NA)

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:

Magnesiun CI brief — competitive landscape report
Magnesiun updates RSS · CI watch RSS
Federal University of São Paulo portfolio CI

Frequently asked questions about Magnesiun

What is Magnesiun?

Magnesiun is a Small molecule drug developed by Federal University of São Paulo.

Who makes Magnesiun?

Magnesiun is developed by Federal University of São Paulo (see full Federal University of São Paulo pipeline at /company/federal-university-of-s-o-paulo).

Is Magnesiun also known as anything else?

Magnesiun is also known as NMDA receptor antagonist.

What development phase is Magnesiun in?

Magnesiun is in Phase 1.

Manufacturer: Federal University of São Paulo — full pipeline
Therapeutic area: All drugs in Other
Also known as: NMDA receptor antagonist

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