CABLIVI

(Caplacizumab)

Phase 2Monoclonal antibody

GGenzyme, a Sanofi Company

CABLIVI is one of 38 small molecule programs targeting Thrombocytopenic Purpura. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Thrombocytopenic PurpuraActive, not recruiting

Thrombotic Thrombocytopenic PurpuraActive, not recruiting

Thrombocytopenic PurpuraPreclinical

Active, not recruiting

Thrombotic Thrombocytopenic PurpuraPhase 2

Active, not recruiting

Competition

Competitive Landscape

47 competitors in Thrombocytopenic Purpura

#DrugCompanyPhaseTrials

Promacta

GSK

Phase 3

11 2

Rayos

RRoxane Laboratories

Phase 3

4 3

Decadron

AAspen Global Incorporated

Phase 3

3 4

Doptelet

AAkarx

Phase 3

2 5

Igpro10

CSL Behring

Approved

1 6

Rituxan

Roche

Phase 2

6 7

AMG 531

Amgen

Phase 3

3 8

Fostamatinib Bid

RRigel Pharmaceuticals

Phase 3

4 9

Immunoglobulin

Sanofi

Phase 2

2 10

Doxil

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Not yet recruiting

Outcome

NCT06358703

Clinical

Trials by Indication[1]

Thrombotic Thrombocytopenic Purpura4 trials

Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

Completed· Sanofi logo

Sanofi·Phase 3·NCT05468320·51 enrolled

Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Completed·AAblynx, a Sanofi company·Phase 2·NCT01151423·75 enrolled

Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

Completed·AAblynx, a Sanofi company·Phase 3·NCT02553317·145 enrolled

Show 1 more trial

A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Completed· Sanofi logo

Sanofi·Phase 2/3·NCT04074187·21 enrolled

Thrombocytopenic Purpura1 trial

Retrospective Study on Caplacizumab-treated Pediatric Patients With Immune-mediated Thrombocytopenic Purpura (iTTP)

Completed· Sanofi logo

Sanofi··NCT05263193·4 enrolled

Observational Study1 trial

A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT05785468·1 enrolled

APL1 trial

Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

Completed·AAblynx, a Sanofi company·Phase 1·NCT02189733·24 enrolled

TED1 trial

Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02878603·104 enrolled

2 more indications

Outcome1 trial

Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors

Not yet recruiting·UUS Thrombotic Microangiopathy Alliance··NCT06358703·116 enrolled

Efficacy1 trial

Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP

Terminated·UUniversity Hospital, Rouen·Phase 2·NCT04720261·58 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 6, 2019

CABLIVI

BLA BLA761112

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Caplacizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Caplacizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Caplacizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761112). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Genzyme, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 2[1]
Company: GGenzyme, a Sanofi Company

CABLIVI

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Trials by Indication[1]

Thrombotic Thrombocytopenic Purpura4 trials

Thrombocytopenic Purpura1 trial

Observational Study1 trial

APL1 trial

TED1 trial

Outcome1 trial

Efficacy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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