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phytomenadione

Instituto Mexicano del Seguro Social · Phase 2 active Small molecule

phytomenadione is a Small molecule drug developed by Instituto Mexicano del Seguro Social. It is currently in Phase 2 development for Antibiotic-Induced Hypoprothrombinemia, Anticoagulant-Induced Prothrombin Deficiency, Factor II deficiency. Also known as: vitamin K.

Likelihood of approval
13.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Cardiovascular Phase 3 risk -2.0pp
    Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 namephytomenadione
Also known asvitamin K
SponsorInstituto Mexicano del Seguro Social
TargetAlpha-synuclein
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about phytomenadione

What is phytomenadione?

phytomenadione is a Small molecule drug developed by Instituto Mexicano del Seguro Social, indicated for Antibiotic-Induced Hypoprothrombinemia, Anticoagulant-Induced Prothrombin Deficiency, Factor II deficiency.

What is phytomenadione used for?

phytomenadione is indicated for Antibiotic-Induced Hypoprothrombinemia, Anticoagulant-Induced Prothrombin Deficiency, Factor II deficiency, Hypocalcemia, Neonatal Hemorrhagic Disease.

Who makes phytomenadione?

phytomenadione is developed by Instituto Mexicano del Seguro Social (see full Instituto Mexicano del Seguro Social pipeline at /company/instituto-mexicano-del-seguro-social).

Is phytomenadione also known as anything else?

phytomenadione is also known as vitamin K.

What development phase is phytomenadione in?

phytomenadione is in Phase 2.

What does phytomenadione target?

phytomenadione targets Alpha-synuclein.

Related

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