Last reviewed 2026-05-27 · How we verify

Enteric-coated aspirin caplets

PLx Pharma · Phase 3 active Small molecule Under review Quality 0/100

Enteric-coated aspirin caplets is a Antiplatelet agent / NSAID Small molecule drug developed by PLx Pharma. It is currently in Phase 3 development for Cardiovascular event prevention (secondary prevention of myocardial infarction and stroke), Primary prevention of cardiovascular disease in high-risk patients.

Aspirin inhibits platelet aggregation by irreversibly acetylating cyclooxygenase (COX) enzymes, reducing thromboxane A2 production and preventing clot formation.

Enteric-coated aspirin caplets are a type of medication that belongs to the class of small molecule inhibitors. They work by inhibiting the enzyme cyclooxygenase, which is involved in the production of certain chemicals in the body.

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 name	Enteric-coated aspirin caplets
Sponsor	PLx Pharma
Drug class	Antiplatelet agent / NSAID
Target	Cyclooxygenase-1 (COX-1), Cyclooxygenase-2 (COX-2)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Aspirin works by blocking COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins and thromboxane A2. By preventing thromboxane A2 synthesis in platelets, aspirin reduces platelet activation and aggregation, thereby decreasing the risk of thrombotic events. The enteric coating delays dissolution until the drug reaches the small intestine, reducing gastric irritation while maintaining the antiplatelet effect.

Approved indications

Cardiovascular event prevention (secondary prevention of myocardial infarction and stroke)
Primary prevention of cardiovascular disease in high-risk patients

Common side effects

Gastrointestinal bleeding
Dyspepsia
Nausea
Abdominal pain
Hemorrhage

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.

Source	Used for
ClinicalTrials.gov	Trial 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:

Enteric-coated aspirin caplets CI brief — competitive landscape report
Enteric-coated aspirin caplets updates RSS · CI watch RSS
PLx Pharma portfolio CI

Frequently asked questions about Enteric-coated aspirin caplets

What is Enteric-coated aspirin caplets?

Enteric-coated aspirin caplets is a Antiplatelet agent / NSAID drug developed by PLx Pharma, indicated for Cardiovascular event prevention (secondary prevention of myocardial infarction and stroke), Primary prevention of cardiovascular disease in high-risk patients.

How does Enteric-coated aspirin caplets work?

Aspirin inhibits platelet aggregation by irreversibly acetylating cyclooxygenase (COX) enzymes, reducing thromboxane A2 production and preventing clot formation.

What is Enteric-coated aspirin caplets used for?

Enteric-coated aspirin caplets is indicated for Cardiovascular event prevention (secondary prevention of myocardial infarction and stroke), Primary prevention of cardiovascular disease in high-risk patients.

Who makes Enteric-coated aspirin caplets?

Enteric-coated aspirin caplets is developed by PLx Pharma (see full PLx Pharma pipeline at /company/plx-pharma).

What drug class is Enteric-coated aspirin caplets in?

Enteric-coated aspirin caplets belongs to the Antiplatelet agent / NSAID class. See all Antiplatelet agent / NSAID drugs at /class/antiplatelet-agent-nsaid.

What development phase is Enteric-coated aspirin caplets in?

Enteric-coated aspirin caplets is in Phase 3.

What are the side effects of Enteric-coated aspirin caplets?

Common side effects of Enteric-coated aspirin caplets include Gastrointestinal bleeding, Dyspepsia, Nausea, Abdominal pain, Hemorrhage.

What does Enteric-coated aspirin caplets target?

Enteric-coated aspirin caplets targets Cyclooxygenase-1 (COX-1), Cyclooxygenase-2 (COX-2) and is a Antiplatelet agent / NSAID.

Drug class: All Antiplatelet agent / NSAID drugs
Target: All drugs targeting Cyclooxygenase-1 (COX-1), Cyclooxygenase-2 (COX-2)
Manufacturer: PLx Pharma — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Cardiovascular event prevention (secondary prevention of myocardial infarction and stroke)
Indication: Drugs for Primary prevention of cardiovascular disease in high-risk patients

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