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Miretilan (ENDRALAZINE)

Phase 2 active Small molecule

Miretilan (generic name: ENDRALAZINE) is a endralazine drug. It is currently in Phase 2 development for Hypertensive disorder.

Miretilan works by blocking calcium channels in blood vessels, which helps to lower blood pressure.

Miretilan (Endralazine) is a small molecule drug that targets the voltage-dependent L-type calcium channel subunit alpha-1C. It is used to treat hypertensive disorders. The commercial status of Miretilan is unknown, and it is not FDA-approved. Key safety considerations include its half-life of 5.6 hours and bioavailability of 75%. Further information on its generic status and patent status is not available.

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 nameENDRALAZINE
Drug classendralazine
TargetVoltage-dependent L-type calcium channel subunit alpha-1C
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Mechanism of action

When you have high blood pressure, your blood vessels are like narrow roads that are congested with traffic. Miretilan helps to widen these roads by blocking the calcium channels that control the flow of calcium into the muscle cells of the blood vessel walls. This allows the blood vessels to relax and widen, which helps to lower blood pressure.

Approved indications

Common side effects

No common side effects on file.

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 Miretilan

What is Miretilan?

Miretilan (ENDRALAZINE) is a endralazine drug, indicated for Hypertensive disorder.

How does Miretilan work?

Miretilan works by blocking calcium channels in blood vessels, which helps to lower blood pressure.

What is Miretilan used for?

Miretilan is indicated for Hypertensive disorder.

What is the generic name of Miretilan?

ENDRALAZINE is the generic (nonproprietary) name of Miretilan.

What drug class is Miretilan in?

Miretilan belongs to the endralazine class. See all endralazine drugs at /class/endralazine.

What development phase is Miretilan in?

Miretilan is in Phase 2.

What does Miretilan target?

Miretilan targets Voltage-dependent L-type calcium channel subunit alpha-1C and is a endralazine.

Related

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