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Lanitop (METILDIGOXIN)

Phase 2 active Small molecule

Lanitop (generic name: METILDIGOXIN) is a metildigoxin drug. It is currently in Phase 2 development.

Lanitop works by blocking the sodium-potassium pump in the heart, which helps regulate the balance of sodium and potassium ions.

Lanitop, also known as metildigoxin, is a small molecule drug that targets the sodium/potassium-transporting ATPase subunit alpha-1. It is a member of the metildigoxin class and works by inhibiting the sodium-potassium pump, leading to increased levels of potassium and decreased levels of sodium in the heart. However, due to the lack of available information, its commercial status, approved indications, half-life, bioavailability, and generic manufacturers are unknown. Lanitop's safety considerations and efficacy are also not well-documented. Further research is needed to fully understand this medication.

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 nameMETILDIGOXIN
Drug classmetildigoxin
TargetSodium/potassium-transporting ATPase subunit alpha-1
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Mechanism of action

Think of the sodium-potassium pump like a gatekeeper that controls the flow of sodium and potassium ions in and out of the heart cells. When Lanitop blocks this pump, it allows more potassium to enter the cells and less sodium to leave, which can help slow down the heart rate and improve its function.

Approved indications

No approved indications tracked.

Common side effects

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 Lanitop

What is Lanitop?

Lanitop (METILDIGOXIN) is a metildigoxin drug.

How does Lanitop work?

Lanitop works by blocking the sodium-potassium pump in the heart, which helps regulate the balance of sodium and potassium ions.

What is the generic name of Lanitop?

METILDIGOXIN is the generic (nonproprietary) name of Lanitop.

What drug class is Lanitop in?

Lanitop belongs to the metildigoxin class. See all metildigoxin drugs at /class/metildigoxin.

What development phase is Lanitop in?

Lanitop is in Phase 2.

What are the side effects of Lanitop?

Common side effects of Lanitop include Cardiac failure, N-terminal prohormone brain natriuretic peptide increased, Wound haemorrhage, Toxic neuropathy, Bradycardia, Refractory anaemia with an excess of blasts.

What does Lanitop target?

Lanitop targets Sodium/potassium-transporting ATPase subunit alpha-1 and is a metildigoxin.

Related

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