Last reviewed 2026-05-29 · How we verify

AZD5718 IR tablet

AstraZeneca · Phase 1 active Small molecule ✓ Verified May 2026 Quality 10/100

AZD5718 IR tablet is a Small molecule drug developed by AstraZeneca. It is currently in Phase 1 development.

AZD5718 IR tablet is being studied in a clinical trial for high risk coronary artery disease. The trial aims to estimate the effect of AZD5718 on the pharmacokinetics of rosuvastatin.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	AZD5718 IR tablet
Sponsor	AstraZeneca
Modality	Small molecule
Phase	Phase 1

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet (PHASE1)

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:

AZD5718 IR tablet CI brief — competitive landscape report
AZD5718 IR tablet updates RSS · CI watch RSS
AstraZeneca portfolio CI

Frequently asked questions about AZD5718 IR tablet

What is AZD5718 IR tablet?

AZD5718 IR tablet is a Small molecule drug developed by AstraZeneca.

Who makes AZD5718 IR tablet?

AZD5718 IR tablet is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

What development phase is AZD5718 IR tablet in?

AZD5718 IR tablet is in Phase 1.

Manufacturer: AstraZeneca — full pipeline

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