Last reviewed 2026-05-29 · How we verify

Itolizumab [Bmab 600]

Equillium · Phase 1 active Small molecule ✓ Verified May 2026

Itolizumab [Bmab 600] is a Small molecule drug developed by Equillium. It is currently in Phase 1 development. Also known as: Bmab600, Itolizumab.

Itolizumab (Bmab 600) is an antibody that inhibits the T-cell differentiation antigen CD6, classified as an inhibitor. It works by targeting CD6, a molecular target involved in the modulation of immune responses.

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	Itolizumab [Bmab 600]
Also known as	Bmab600, Itolizumab
Sponsor	Equillium
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Itolizumab [Bmab 600] CI brief — competitive landscape report
Itolizumab [Bmab 600] updates RSS · CI watch RSS
Equillium portfolio CI

Frequently asked questions about Itolizumab [Bmab 600]

What is Itolizumab [Bmab 600]?

Itolizumab [Bmab 600] is a Small molecule drug developed by Equillium.

Who makes Itolizumab [Bmab 600]?

Itolizumab [Bmab 600] is developed by Equillium (see full Equillium pipeline at /company/equillium).

Is Itolizumab [Bmab 600] also known as anything else?

Itolizumab [Bmab 600] is also known as Bmab600, Itolizumab.

What development phase is Itolizumab [Bmab 600] in?

Itolizumab [Bmab 600] is in Phase 1.

Manufacturer: Equillium — full pipeline
Also known as: Bmab600, Itolizumab

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