CDEK
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cemiplimab

Trade name: libtayo

mAbapprovedBreakthrough Therapy FDA

Approved

Sep 28, 2018

Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication for the treatment of squamous cell skin cancer. Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway. — Wikipedia

Clinical trial activity

170 trials · 113 clinical orgs · 1 marketing orgs

Phase 1
63
Phase 2
130
Phase 3
16
Phase 4
0

Earliest trial started Jan 1, 2015 (NCT02383212)

Timeline

2010s

  1. Jan 1, 2015

    Regeneron — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Regeneron — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2017

    Regeneron — Earliest Phase 3 Sponsor(trial)

  4. Sep 28, 2018

    Regeneron — Earliest FDA Approval

  5. Sep 28, 2018

    Regeneron — Marketing Organization

  6. Sep 28, 2018

    Regeneron — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughSep 28, 2018

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • cemiplimab
  • cemiplimab-rwlc
  • regn2810

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06900595Phase 2Jul 19, 2026National Cancer Institute (NCI)
NCT07281768Phase 2Mar 31, 2026Johns Hopkins University, Regeneron
NCT07281417Phase 2Feb 27, 2026National Cancer Institute (NCI), Ohio State University
NCT07224022Phase 2Jan 31, 2026Duke University, Regeneron
NCT07274384Phase 2Jan 1, 2026Mario Negri Institute, Vita-Salute University of Milano. Italy
NCT07179315Phase 2Jan 1, 2026University of Chicago
NCT07223541Phase 2Dec 31, 2025Regeneron, University of Oklahoma
NCT07147231Phase 1/Phase 2 (Phase 2)Dec 31, 2025Johns Hopkins University, National Cancer Institute (NCI)
NCT07101822Phase 2Dec 31, 2025Albert Einstein Israelite Hospital
NCT06860815Phase 2Dec 12, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06790602Phase 2Nov 30, 2025Regeneron, University of California, San Diego
NCT07188896Phase 2Nov 30, 2025Hoosier Cancer Research Network, Regeneron, Vanderbilt University
NCT07020065Phase 2Nov 30, 2025Swiss Cancer Institute
NCT06931717Phase 3Nov 30, 2025ETOP IBCSG Partners Foundation, National University of Singapore, Regeneron
NCT06980038Phase 2Nov 21, 2025Johns Hopkins University, National Cancer Institute (NCI)
NCT07195734Phase 2Nov 14, 2025National Cancer Institute (NCI), NRG Oncology
NCT06908304Phase 3Nov 3, 2025Maia Biotechnology
NCT07101848Phase 2Nov 1, 2025Albert Einstein Israelite Hospital
NCT06943664Phase 2Nov 1, 2025Rakuten, State University of New York, Buffalo
NCT07251413Phase 1/Phase 2 (Phase 2)Oct 22, 2025Institute of Oncology Dr. Rosell (IOR), Regeneron, University of Barcelona
Showing 20 of 170 trials
Page 1 / 9

Organizations

Research & Development (113)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RegeneronFor profit994642015
SanofiFor profit27842015
National Cancer Institute (NCI)Government15732020
University of Texas at HoustonAcademic/Hospital111022018
Johns Hopkins UniversityAcademic/Hospital7412019
BiontechFor profit5322019
University of South FloridaAcademic/Hospital5522020
GenzymeFor profit4012020
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital4422021
Columbia UniversityAcademic/Hospital3312019
Duke UniversityAcademic/Hospital3312023
Harvard UniversityAcademic/Hospital3222019
Ohio State UniversityAcademic/Hospital3212021
Albert Einstein Israelite HospitalAcademic/Hospital2212025
City of Hope National Medical CenterAcademic/Hospital2212023
Emory UniversityAcademic/Hospital2222020
Icahn School of Medicine at Mount SinaiAcademic/Hospital2222022
ISA PharmaceuticalsFor profit2112018
Maia BiotechnologyFor profit2222022
Mayo ClinicAcademic/Hospital2222024
113 organizations
Page 1 / 6

Marketing (2)

OrganizationOrg typeRelationshipDate
RegeneronFor profitMKTGSep 28, 2018
RegeneronFor profitNDASep 28, 2018