Last reviewed 2026-04-19 · How we verify

Docirbrutinib

Carna Biosciences, Inc. · Phase 1 active Small molecule

Docirbrutinib is a Small molecule drug developed by Carna Biosciences, Inc.. It is currently in Phase 1 development. Also known as: AS-1763.

Likelihood of approval

9.6% 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).

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	Docirbrutinib
Also known as	AS-1763
Sponsor	Carna Biosciences, Inc.
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma (Phase 1)

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:

Docirbrutinib CI brief — competitive landscape report
Docirbrutinib updates RSS · CI watch RSS
Carna Biosciences, Inc. portfolio CI

Frequently asked questions about Docirbrutinib

What is Docirbrutinib?

Docirbrutinib is a Small molecule drug developed by Carna Biosciences, Inc..

Who makes Docirbrutinib?

Docirbrutinib is developed by Carna Biosciences, Inc. (see full Carna Biosciences, Inc. pipeline at /company/carna-biosciences-inc).

Is Docirbrutinib also known as anything else?

Docirbrutinib is also known as AS-1763.

What development phase is Docirbrutinib in?

Docirbrutinib is in Phase 1.

Manufacturer: Carna Biosciences, Inc. — full pipeline
Therapeutic area: All drugs in Other
Also known as: AS-1763

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