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Calblock (AZELNIDIPINE)

Phase 3 active Small molecule

Calblock (generic name: AZELNIDIPINE) is a azelnidipine drug. It is currently in Phase 3 development for Hypertensive disorder.

Calblock works by blocking calcium channels in blood vessel walls, which helps to relax the vessels and lower blood pressure.

Calblock (azelnidipine) is a small molecule drug that targets voltage-gated L-type calcium channels. It is used to treat hypertensive disorders by relaxing blood vessels and reducing blood pressure. The commercial status of Calblock is unknown, and it may be patented or have generic manufacturers. Key safety considerations include potential interactions with other medications and monitoring of blood pressure. Calblock is not FDA-approved, but it is approved in other countries for its indicated use.

Likelihood of approval
56.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameAZELNIDIPINE
Drug classazelnidipine
TargetVoltage-gated L-type calcium channel
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

Imagine your blood vessels are like roads in your body. When calcium channels are open, they allow calcium to flow in and cause the roads to narrow and get congested. Calblock blocks these channels, allowing the roads to relax and widen, which helps to reduce blood pressure.

Approved indications

Common side effects

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 Calblock

What is Calblock?

Calblock (AZELNIDIPINE) is a azelnidipine drug, indicated for Hypertensive disorder.

How does Calblock work?

Calblock works by blocking calcium channels in blood vessel walls, which helps to relax the vessels and lower blood pressure.

What is Calblock used for?

Calblock is indicated for Hypertensive disorder.

What is the generic name of Calblock?

AZELNIDIPINE is the generic (nonproprietary) name of Calblock.

What drug class is Calblock in?

Calblock belongs to the azelnidipine class. See all azelnidipine drugs at /class/azelnidipine.

What development phase is Calblock in?

Calblock is in Phase 3.

What are the side effects of Calblock?

Common side effects of Calblock include Cerebral infarction, Hepatic function abnormal, Renal impairment, Cardiac failure, Platelet count decreased, Interstitial lung disease.

What does Calblock target?

Calblock targets Voltage-gated L-type calcium channel and is a azelnidipine.

Related

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