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Free [Per/Ind + Aml]

Institut de Recherches Internationales Servier · Phase 3 active Small molecule ✓ Verified May 2026

Free [Per/Ind + Aml] is a ACE inhibitor and calcium channel blocker combination Small molecule drug developed by Institut de Recherches Internationales Servier. It is currently in Phase 3 development for Hypertension.

A fixed-dose combination of perindopril (ACE inhibitor) and amlodipine (calcium channel blocker) that reduces blood pressure through dual vasodilation and renin-angiotensin system inhibition.

There is limited information available on the modality of Free [Per/Ind + Aml] due to unknown data on ChEMBL.

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 nameFree [Per/Ind + Aml]
SponsorInstitut de Recherches Internationales Servier
Drug classACE inhibitor and calcium channel blocker combination
TargetACE (angiotensin-converting enzyme) and L-type voltage-gated calcium channels
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

Perindopril inhibits angiotensin-converting enzyme, preventing formation of angiotensin II and reducing vasoconstriction and aldosterone secretion. Amlodipine blocks L-type calcium channels in vascular smooth muscle, causing direct vasodilation. Together, these complementary mechanisms provide synergistic blood pressure reduction with improved tolerability compared to monotherapy.

Approved indications

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 Free [Per/Ind + Aml]

What is Free [Per/Ind + Aml]?

Free [Per/Ind + Aml] is a ACE inhibitor and calcium channel blocker combination drug developed by Institut de Recherches Internationales Servier, indicated for Hypertension.

How does Free [Per/Ind + Aml] work?

A fixed-dose combination of perindopril (ACE inhibitor) and amlodipine (calcium channel blocker) that reduces blood pressure through dual vasodilation and renin-angiotensin system inhibition.

What is Free [Per/Ind + Aml] used for?

Free [Per/Ind + Aml] is indicated for Hypertension.

Who makes Free [Per/Ind + Aml]?

Free [Per/Ind + Aml] is developed by Institut de Recherches Internationales Servier (see full Institut de Recherches Internationales Servier pipeline at /company/institut-de-recherches-internationales-servier).

What drug class is Free [Per/Ind + Aml] in?

Free [Per/Ind + Aml] belongs to the ACE inhibitor and calcium channel blocker combination class. See all ACE inhibitor and calcium channel blocker combination drugs at /class/ace-inhibitor-and-calcium-channel-blocker-combination.

What development phase is Free [Per/Ind + Aml] in?

Free [Per/Ind + Aml] is in Phase 3.

What are the side effects of Free [Per/Ind + Aml]?

Common side effects of Free [Per/Ind + Aml] include Cough, Peripheral edema, Dizziness, Headache, Fatigue.

What does Free [Per/Ind + Aml] target?

Free [Per/Ind + Aml] targets ACE (angiotensin-converting enzyme) and L-type voltage-gated calcium channels and is a ACE inhibitor and calcium channel blocker combination.

Related

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