Last reviewed 2026-04-20 · How we verify

Dazukibart (dazukibart)

Pfizer Inc. · Phase 3 active Quality 3/100

Dazukibart (generic name: dazukibart) is a drug developed by Pfizer Inc.. It is currently in Phase 3 development.

Dazukibart, currently in Phase 3 development by Pfizer Inc., is a novel therapeutic agent with a key composition patent expiring in 2028. The drug's primary strength lies in its advanced mechanism of action, which positions it to potentially address unmet needs in its primary indication. The primary risk is the competitive landscape, which remains undefined but could pose significant challenges post-launch.

Likelihood of approval

61.3% 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).
Big-pharma sponsor +3.0pp
Pfizer Inc. 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	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	dazukibart
Sponsor	Pfizer Inc.
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies (PHASE3)

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:

Dazukibart CI brief — competitive landscape report
Dazukibart updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about Dazukibart

What is Dazukibart?

Dazukibart (dazukibart) is a pharmaceutical drug developed by Pfizer Inc..

Who makes Dazukibart?

Dazukibart is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of Dazukibart?

dazukibart is the generic (nonproprietary) name of Dazukibart.

What development phase is Dazukibart in?

Dazukibart is in Phase 3.

Manufacturer: Pfizer Inc. — full pipeline
Therapeutic area: All drugs in Other

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