CABLIVI

(Caplacizumab)

PreclinicalMonoclonal antibody

GGenzyme, a Sanofi Company

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

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Thrombocytopenic PurpuraActive, not recruiting

Thrombocytopenic PurpuraPreclinical

Active, not recruiting

Competition

Competitive Landscape

5 competitors in Thrombocytopenic Purpura

#DrugCompanyPhaseTrials

CABLIVI

GGenzyme, a Sanofi Company

Preclinical

1 2

Inactivated Trivalent Influenza Vaccine

AAdvagene Biopharma Co. Ltd.

Preclinical

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

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

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

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

Completed· Sanofi logo

Sanofi·Phase 2/3·NCT04074187·21 enrolled

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

Show 1 more trial

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

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: Preclinical[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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