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Vikasolum (MENADIONE SODIUM BISULFITE)

Phase 2 active Small molecule

Vikasolum (generic name: MENADIONE SODIUM BISULFITE) is a drug. It is currently in Phase 2 development.

Vikasolum works by interacting with and stabilizing vitamin K-dependent proteins in the body.

Vikasolum, also known as Menadione Sodium Bisulfite, is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it has not been approved by the FDA for any indications. As a small molecule, it is likely to work by interacting with specific biological pathways, but the exact mechanism is unknown. Further research is needed to understand its potential therapeutic applications and safety profile.

Likelihood of approval
15.3% 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).
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 nameMENADIONE SODIUM BISULFITE
TargetAldose reductase
ModalitySmall molecule
Therapeutic areaHematology
PhasePhase 2

Mechanism of action

Think of vitamin K-dependent proteins like the locks on a door. Vikasolum helps keep these locks stable, allowing them to function properly. This is important because these proteins play a crucial role in blood clotting and other bodily processes.

Approved indications

No approved indications tracked.

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 Vikasolum

What is Vikasolum?

Vikasolum (MENADIONE SODIUM BISULFITE) is a Small molecule drug.

How does Vikasolum work?

Vikasolum works by interacting with and stabilizing vitamin K-dependent proteins in the body.

What is the generic name of Vikasolum?

MENADIONE SODIUM BISULFITE is the generic (nonproprietary) name of Vikasolum.

What development phase is Vikasolum in?

Vikasolum is in Phase 2.

What does Vikasolum target?

Vikasolum targets Aldose reductase.

Related

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