CDEK
← All drugs Report issue

pembrolizumab

Trade name: keytruda

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Sep 4, 2014

Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody, more specifically a PD-1 inhibitor, used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is administered by slow intravenous injection. — Wikipedia

Clinical trial activity

2,255 trials · 966 clinical orgs · 1 marketing orgs

Phase 1
831
Phase 2
1708
Phase 3
308
Phase 4
12

Earliest trial started Jun 1, 2004 (NCT00179166)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Merck — Earliest Phase 1 Sponsor(trial)

  2. Nov 19, 2012

    Orphan Drug Designation

  3. Jan 1, 2013

    Merck — Earliest Phase 3 Sponsor(trial)

  4. Sep 4, 2014

    Merck — Earliest FDA Approval

  5. Sep 4, 2014

    Merck — Marketing Organization

  6. Sep 4, 2014

    Merck — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAcceleratedBreakthroughSep 4, 2014

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • grapiprant and pembrolizumab
  • keytruda
  • keytruda
  • keytruda
  • keytruda
  • keytruda
  • lambrolizumab
  • lambrolizumab
  • lambrolizumab
  • lambrolizumab
  • lambrolizumab
  • mk-3475
  • mk-3475
  • mk-3475
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pembrolizumab
  • pemprolizumab
  • sch-900475

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07275216Phase 2Jul 1, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07267338Phase 2Jun 30, 2026Huazhong University of Science and Technology, Lepu Medical Technology (Beijing) Co., Ltd., Merck
NCT07283731Phase 2Jun 2, 2026Exelixis, University of Texas at Houston
NCT07061964Phase 2Jun 1, 2026National Cancer Institute (NCI), SWOG Cancer Research Network
NCT07037004Phase 2May 4, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07300475Phase 1Mar 31, 2026Washington University in St. Louis
NCT07199413Phase 1Mar 1, 2026Medical College of Wisconsin
NCT07187778Phase 2Feb 28, 2026Merck, University of Texas at Houston
NCT07302347Phase 1/Phase 2 (Phase 2)Feb 20, 2026Merck
NCT07286149Phase 1/Phase 2 (Phase 2)Feb 9, 2026Daiichi Sankyo, Merck
NCT07221942Phase 2Jan 31, 2026Department of Defense, Temple University
NCT07178730Phase 3Jan 31, 2026Ev. Hospital Bethesda, Moenchengladbach, Gilead Sciences, Kliniken Essen-Mitte, Germany, Ludwig Maximilians University, Ruhr University Bochum, West German Study Group
NCT07264075Phase 3Jan 31, 2026Akeso Pharmaceuticals, Inc., Groupe Oncologie Radiotherapie Tete et Cou, Summit Therapeutics
NCT07252739Phase 2Jan 14, 2026Merck
NCT07290894Phase 2Dec 31, 2025Fondazione Giovanni Pascale
NCT07213934Phase 1/Phase 2 (Phase 2)Dec 31, 2025University of Cincinnati
NCT07276880Phase 2Dec 31, 2025Merck, National Cancer Institute (NCI), University of North Carolina at Chapel Hill
NCT07269158Phase 1/Phase 2 (Phase 2)Dec 31, 2025Yonsei University
NCT07264816Phase 2Dec 31, 2025Baili Pharmaceutical Group
NCT07261683Phase 2Dec 31, 2025Fudan University
Showing 20 of 2,255 trials
Page 1 / 113

Organizations

Research & Development (966)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit94026952011
National Cancer Institute (NCI)Government2277542010
University of Texas at HoustonAcademic/Hospital777332015
Harvard UniversityAcademic/Hospital594742015
University of California, San FranciscoAcademic/Hospital353232010
EisaiFor profit34732015
Mayo ClinicAcademic/Hospital332732015
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital282822017
University of PittsburghAcademic/Hospital282542014
Eli LillyFor profit241332014
IncyteFor profit241632014
Johns Hopkins UniversityAcademic/Hospital231932013
University of LondonAcademic/Hospital231432013
Chinese Academy of Medical SciencesAcademic/Hospital221952019
AmgenFor profit211532014
AstraZenecaFor profit211332016
University of ChicagoAcademic/Hospital212122015
University of South FloridaAcademic/Hospital211732015
City of Hope National Medical CenterAcademic/Hospital201822015
State University of New York, BuffaloAcademic/Hospital201912016
966 organizations
Page 1 / 49

Marketing (2)

OrganizationOrg typeRelationshipDate
MerckFor profitMKTGSep 4, 2014
MerckFor profitNDASep 4, 2014