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aldesleukin

Trade name: Proleukin

Recombinant proteinapprovedOrphan Drug FDA

Approved

May 5, 1992

Interleukin-2 (IL-2) is an interleukin, which is a type of cytokine signaling molecule forming part of the immune system. It is a 15.5–16 kDa protein that regulates the activities of white blood cells (leukocytes, often lymphocytes) that are responsible for immunity. IL-2 is part of the body's natural response to microbial infection, and in discriminating between foreign ("non-self") and "self". IL-2 mediates its effects by binding to IL-2 receptors, which are expressed by lymphocytes. The major sources of IL-2 are activated CD4+ T cells and activated CD8+ T cells. Put shortly the function of IL-2 is to stimulate the growth of helper, cytotoxic and regulatory T cells. — Wikipedia

Clinical trial activity

700 trials · 342 clinical orgs · 2 marketing orgs

Phase 1
332
Phase 2
454
Phase 3
49
Phase 4
10

Earliest trial started Apr 1, 1991 (NCT00018941)

Timeline

1980s

  1. Sep 14, 1988

    Orphan Drug Designation

1990s

  1. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1991

    Earliest Phase 3 Sponsor(trial)

  3. May 5, 1992

    Chiron — Earliest FDA Approval

  4. May 5, 1992

    Chiron — Marketing Organization

  5. May 5, 1992

    Chiron — NDA Organization

  6. May 5, 1992

    Clinigen, Inc. — NDA Secondary Org

  7. Jan 1, 1994

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMay 5, 1992

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 125-l-serine-2-133-interleukin 2 (human reduced)
  • 2-133-interleukin 2 (human reduced), 125-l-serine-
  • aldesleukin
  • aldesleukin
  • aldesleukin
  • aldesleukin
  • aldesleukin
  • aldesleukin
  • aldesleukin
  • aldesleukin
  • aldesleukine
  • bay 50-4798
  • bay 50-4798
  • bay 50-4798
  • bay 50-4798
  • human interleukin-2
  • il2
  • il-2
  • ilt-101
  • interleukin 2
  • interleukin 2
  • interleukin-2
  • interleukin-2(2-133),125-ser
  • interleukin-2 aldesleukin
  • interleukine-2
  • proleukin
  • proleukin
  • proleukin
  • proleukin
  • proleukin
  • recombinant interleukin-2 human
  • t-cells rituximab + il-2

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07183852Phase 1Mar 31, 2026Vastra Gotaland Region
NCT07288073Phase 2Jan 31, 2026Harvard University, Iovance
NCT07225439Phase 1Dec 31, 2025Case Western Reserve University, Incyte
NCT06904066Phase 1Dec 2, 2025National Cancer Institute (NCI)
NCT06961357Phase 1/Phase 2 (Phase 2)Dec 1, 2025University of South Florida
NCT07255664Phase 1/Phase 2 (Phase 2)Nov 13, 2025Curacell Holding AB, Institut für Klinische Krebsforschung IKF GmbH
NCT07192900Phase 1Oct 31, 2025Allegheny Health Network, Iovance, Miltenyi Biotec, Inc., University of Pittsburgh
NCT07105176Phase 1Aug 30, 2025Qingdao Sino-Cell Biomedicine Co.,Ltd.
NCT06920199Early Phase 1 (Phase 1)Jun 14, 2025Jiao Tong University
NCT07063875Phase 1/Phase 2 (Phase 2)Jun 1, 2025University of New South Wales
NCT06971913Phase 2May 20, 2025Peking University
NCT06924762Phase 2/Phase 3 (Phase 3)Mar 19, 2025Central South University, Fujian Medical University, Guangzhou Medical University, Hacettepe University, Hangzhou Third Hospital, Huazhong University of Science and Technology, Sichuan University, Sun Yat-Sen University, The First People's Hospital of Changde City
NCT06884670Phase 2Mar 18, 2025Nanjing Medical University
NCT06598371Phase 1/Phase 2 (Phase 2)Mar 11, 2025KSQ Therapeutics, Inc., University of Texas at Houston
NCT06690281Phase 2Jan 1, 2025National Cancer Institute (NCI)
NCT06630611Phase 2Dec 31, 2024Banc de Sang i Teixits, Universidad Autonoma de Barcelona
NCT06190249Phase 1Dec 31, 2024Case Western Reserve University, Iovance
NCT06626256Phase 1Dec 30, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06677710Phase 1Nov 1, 2024Indapta Therapeutics, INC.
NCT06640582Phase 1/Phase 2 (Phase 2)Oct 20, 2024Essen Biotech
Showing 20 of 700 trials
Page 1 / 35

Organizations

Research & Development (342)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government22711751991
National Institutes of Health (NIH)Government59741991
National Institute of Allergy and Infectious Diseases (NIAID)Government423941991
University of WashingtonAcademic/Hospital373241995
University of Texas at HoustonAcademic/Hospital312741995
University of MinnesotaAcademic/Hospital272441999
Harvard UniversityAcademic/Hospital241831993
Peking UniversityAcademic/Hospital242442012
ChironFor profit18751997
Prometheus Inc.For profit18232006
University of South FloridaAcademic/Hospital181732000
IovanceFor profit12132012
University of CopenhagenAcademic/Hospital12932009
University of California, Los AngelesAcademic/Hospital10732000
Wayne State UniversityAcademic/Hospital10731997
City of Hope National Medical CenterAcademic/Hospital9522000
Cornell UniversityAcademic/Hospital9721995
Iltoo PharmaFor profit9122014
State University of New York, BuffaloAcademic/Hospital8631996
St. Jude Children's HospitalAcademic/Hospital8831998
342 organizations
Page 1 / 18

Marketing (3)

OrganizationOrg typeRelationshipDate
ChironFor profitMKTGMay 5, 1992
ChironFor profitNDAMay 5, 1992
Clinigen, Inc.For profitNDA2May 5, 1992