Last reviewed 2026-05-24 · How we verify

SR-B + Epratuzumab

Charite University, Berlin, Germany · Phase 3 active Small molecule Under review Quality 0/100

SR-B + Epratuzumab is a Monoclonal antibody Small molecule drug developed by Charite University, Berlin, Germany. It is currently in Phase 3 development for Systemic lupus erythematosus (SLE), Lupus nephritis. Also known as: Epratuzumab.

SR-B combined with epratuzumab targets B cell surface antigens to modulate immune response in autoimmune and inflammatory conditions.

Epratuzumab is an antibody that targets the B-cell receptor CD22, acting as a CD22 inhibitor. It has been studied in combination with SR-B in clinical trials for the treatment of Acute Lymphoblastic Leukemia (ALL).

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	SR-B + Epratuzumab
Also known as	Epratuzumab
Sponsor	Charite University, Berlin, Germany
Drug class	Monoclonal antibody
Target	CD22
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

Epratuzumab is a monoclonal antibody that binds to CD22, a B cell-restricted antigen, leading to B cell modulation and reduced autoimmune activity. The SR-B component likely refers to a specific formulation or combination strategy to enhance therapeutic efficacy in systemic lupus erythematosus and related autoimmune disorders.

Approved indications

Systemic lupus erythematosus (SLE)
Lupus nephritis

Common side effects

Infusion reactions
Infections
Headache
Fatigue

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:

SR-B + Epratuzumab CI brief — competitive landscape report
SR-B + Epratuzumab updates RSS · CI watch RSS
Charite University, Berlin, Germany portfolio CI

Frequently asked questions about SR-B + Epratuzumab

What is SR-B + Epratuzumab?

SR-B + Epratuzumab is a Monoclonal antibody drug developed by Charite University, Berlin, Germany, indicated for Systemic lupus erythematosus (SLE), Lupus nephritis.

How does SR-B + Epratuzumab work?

SR-B combined with epratuzumab targets B cell surface antigens to modulate immune response in autoimmune and inflammatory conditions.

What is SR-B + Epratuzumab used for?

SR-B + Epratuzumab is indicated for Systemic lupus erythematosus (SLE), Lupus nephritis.

Who makes SR-B + Epratuzumab?

SR-B + Epratuzumab is developed by Charite University, Berlin, Germany (see full Charite University, Berlin, Germany pipeline at /company/charite-university-berlin-germany).

Is SR-B + Epratuzumab also known as anything else?

SR-B + Epratuzumab is also known as Epratuzumab.

What drug class is SR-B + Epratuzumab in?

SR-B + Epratuzumab belongs to the Monoclonal antibody class. See all Monoclonal antibody drugs at /class/monoclonal-antibody.

What development phase is SR-B + Epratuzumab in?

SR-B + Epratuzumab is in Phase 3.

What are the side effects of SR-B + Epratuzumab?

Common side effects of SR-B + Epratuzumab include Infusion reactions, Infections, Headache, Fatigue.

What does SR-B + Epratuzumab target?

SR-B + Epratuzumab targets CD22 and is a Monoclonal antibody.

Drug class: All Monoclonal antibody drugs
Target: All drugs targeting CD22
Manufacturer: Charite University, Berlin, Germany — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Systemic lupus erythematosus (SLE)
Indication: Drugs for Lupus nephritis
Also known as: Epratuzumab

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