Last reviewed 2026-05-23 · How we verify

ZOTAROLIMUS

Phase 3 active Small molecule Under review Quality 0/100

ZOTAROLIMUS is a zotarolimus drug. It is currently in Phase 3 development.

Zotarolimus works by binding to the FKBP1A protein, which is involved in the activation of calcineurin and subsequent T-cell activation.

Zotarolimus is a small molecule inhibitor of the FK506-binding protein 1A, used in drug-eluting stents such as the Resolute Integrity Stent to treat conditions including coronary artery disease and myocardial ischemia. It is classified as an inhibitor and has been studied in clinical trials for various coronary artery disease-related conditions.

Likelihood of approval

59.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	ZOTAROLIMUS
Drug class	zotarolimus
Target	Peptidyl-prolyl cis-trans isomerase FKBP1A, Serine/threonine-protein kinase mTOR
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

Think of it like a key fitting into a lock. Zotarolimus is the key that blocks the action of FKBP1A, which is like a switch that turns on T-cell activation. By blocking this switch, zotarolimus helps to prevent the immune system from attacking the transplanted heart tissue.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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:

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

Frequently asked questions about ZOTAROLIMUS

What is ZOTAROLIMUS?

ZOTAROLIMUS is a zotarolimus drug.

How does ZOTAROLIMUS work?

Zotarolimus works by binding to the FKBP1A protein, which is involved in the activation of calcineurin and subsequent T-cell activation.

What drug class is ZOTAROLIMUS in?

ZOTAROLIMUS belongs to the zotarolimus class. See all zotarolimus drugs at /class/zotarolimus.

What development phase is ZOTAROLIMUS in?

ZOTAROLIMUS is in Phase 3.

What does ZOTAROLIMUS target?

ZOTAROLIMUS targets Peptidyl-prolyl cis-trans isomerase FKBP1A, Serine/threonine-protein kinase mTOR and is a zotarolimus.

Drug class: All zotarolimus drugs
Target: All drugs targeting Peptidyl-prolyl cis-trans isomerase FKBP1A, Serine/threonine-protein kinase mTOR
Therapeutic area: All drugs in Immunology

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