Last reviewed 2026-06-02 · How we verify

Sapresta (ARANIDIPINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Sapresta (generic name: ARANIDIPINE) is a aranidipine drug. It is currently in Phase 2 development for Hypertensive disorder.

Aranidipine works by blocking the L-type calcium channel, which reduces the amount of calcium entering the heart and blood vessels, leading to lower blood pressure.

Sapresta is a small molecule modality. It is also known by other names, including ARANIDIPINE, ARANIDIPINO, MPC-1304, MPC1304.

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 name	ARANIDIPINE
Drug class	aranidipine
Target	Voltage-gated L-type calcium channel
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Think of it like a gate that controls the flow of calcium into the heart and blood vessels. When this gate is open, calcium rushes in and makes the heart beat faster and the blood vessels constrict. Aranidipine blocks this gate, slowing down the heart rate and widening the blood vessels, which helps to lower blood pressure.

Approved indications

Hypertensive disorder

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:

Sapresta CI brief — competitive landscape report
Sapresta updates RSS · CI watch RSS

Frequently asked questions about Sapresta

What is Sapresta?

Sapresta (ARANIDIPINE) is a aranidipine drug, indicated for Hypertensive disorder.

How does Sapresta work?

Aranidipine works by blocking the L-type calcium channel, which reduces the amount of calcium entering the heart and blood vessels, leading to lower blood pressure.

What is Sapresta used for?

Sapresta is indicated for Hypertensive disorder.

What is the generic name of Sapresta?

ARANIDIPINE is the generic (nonproprietary) name of Sapresta.

What drug class is Sapresta in?

Sapresta belongs to the aranidipine class. See all aranidipine drugs at /class/aranidipine.

What development phase is Sapresta in?

Sapresta is in Phase 2.

What does Sapresta target?

Sapresta targets Voltage-gated L-type calcium channel and is a aranidipine.

Drug class: All aranidipine drugs
Target: All drugs targeting Voltage-gated L-type calcium channel
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Hypertensive disorder

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