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MabCampath-1h

University of British Columbia · Phase 3 active Small molecule Under review Quality 0/100

MabCampath-1h is a Monoclonal antibody (CD52 antagonist) Small molecule drug developed by University of British Columbia. It is currently in Phase 3 development for Chronic lymphocytic leukemia (CLL), B-cell lymphomas. Also known as: Alemtuzumab.

MabCampath-1h is a humanized monoclonal antibody that binds to CD52 on the surface of lymphocytes, leading to their destruction through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

MabCampath-1h is an antibody that inhibits the CAMPATH-1 antigen. It is being studied in a clinical trial for the treatment of Relapsing Remitting Multiple Sclerosis.

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).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
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 nameMabCampath-1h
Also known asAlemtuzumab
SponsorUniversity of British Columbia
Drug classMonoclonal antibody (CD52 antagonist)
TargetCD52
ModalitySmall molecule
Therapeutic areaOncology, Immunology
PhasePhase 3

Mechanism of action

The drug targets CD52, a glycoprotein expressed on B cells, T cells, and other lymphocytes. Upon binding, it triggers immune-mediated destruction of these cells, resulting in profound lymphocyte depletion. This mechanism is used therapeutically in conditions where reduction of pathogenic lymphocytes is beneficial, such as chronic lymphocytic leukemia and certain autoimmune disorders.

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about MabCampath-1h

What is MabCampath-1h?

MabCampath-1h is a Monoclonal antibody (CD52 antagonist) drug developed by University of British Columbia, indicated for Chronic lymphocytic leukemia (CLL), B-cell lymphomas.

How does MabCampath-1h work?

MabCampath-1h is a humanized monoclonal antibody that binds to CD52 on the surface of lymphocytes, leading to their destruction through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

What is MabCampath-1h used for?

MabCampath-1h is indicated for Chronic lymphocytic leukemia (CLL), B-cell lymphomas.

Who makes MabCampath-1h?

MabCampath-1h is developed by University of British Columbia (see full University of British Columbia pipeline at /company/university-of-british-columbia).

Is MabCampath-1h also known as anything else?

MabCampath-1h is also known as Alemtuzumab.

What drug class is MabCampath-1h in?

MabCampath-1h belongs to the Monoclonal antibody (CD52 antagonist) class. See all Monoclonal antibody (CD52 antagonist) drugs at /class/monoclonal-antibody-cd52-antagonist.

What development phase is MabCampath-1h in?

MabCampath-1h is in Phase 3.

What are the side effects of MabCampath-1h?

Common side effects of MabCampath-1h include Infusion reactions, Lymphopenia, Infections, Anemia, Thrombocytopenia.

What does MabCampath-1h target?

MabCampath-1h targets CD52 and is a Monoclonal antibody (CD52 antagonist).

Related

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