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← All drugs Report issue

Tuberculin, Purified Protein Derivative

Trade name: Tubersol

Vaccineapproved

Approved

Apr 12, 1946

Clinical trial activity

24 trials · 31 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
16
Phase 3
8
Phase 4
2

Earliest trial started Nov 2, 1999 (NCT00000955)

Timeline

1940s

  1. Apr 12, 1946

    Earliest FDA Approval

1990s

  1. Apr 20, 1998

    Par Pharmaceuticals — First NDA Organization

  2. Apr 20, 1998

    Par Pharmaceuticals — NDA Secondary Org

  3. Apr 20, 1998

    Par Pharmaceuticals — NDA Organization

2000s

  1. Feb 24, 2000

    Sanofi-Aventis — NDA Secondary Org

  2. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedApr 12, 1946

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • aplisol
  • aplisol
  • aplitest
  • mycobacterium tuberculosis purified protein derivative
  • purified protein derivative of tuberculin
  • tine test
  • tine test ppd
  • tuberculin
  • tuberculin, old
  • tuberculin ppd
  • tuberculin ppd
  • tuberculin purified protein derivative
  • tuberculin purified protein derivative
  • tuberculin, purified protein derivative
  • tuberculin, purified protein derivative
  • tuberculin,purified protein derivative
  • tuberculin, purified protein derivative of
  • tuberculin, purified protein derivative (ppd)
  • tuberculinum
  • tubersol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06587542Phase 2/Phase 3 (Phase 3)Sep 15, 2024Padjadjaran University
NCT05899179Phase 3Aug 3, 2023Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd., Huazhong University of Science and Technology, Shenzhen Third People's Hospital
NCT07072065Phase 2Apr 1, 2022National University of Malaysia, Padjadjaran University
NCT05027958Early Phase 1 (Phase 1)Dec 7, 2021National Heart, Lung, and Blood Institute (NHLBI)
NCT04288817Phase 3Mar 1, 2020Assiut University
NCT03477448Phase 4Apr 1, 2018Assiut University
NCT03153566Phase 3Jun 1, 2017Assiut University
NCT02336542Phase 2Nov 1, 2014Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd., Fudan University, Huazhong University of Science and Technology, People's Liberation Army of China, Proswell Medical Corporation, Tianjin University
NCT02329730Phase 2Feb 1, 2014Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd., Fudan University, People's Liberation Army of China, Proswell Medical Corporation, Tianjin University
NCT02501421Phase 1Oct 1, 2013National Center for Tuberculosis Problems, Kazakhstan, Research Institute for Biological Safety Problems, Research Institute of Influenza, Russia
NCT01779102Phase 2/Phase 3 (Phase 3)Oct 1, 2013Statens Serum Institut, University of Cape Town
NCT01798095Phase 2Feb 1, 2013INC Research, JHP Pharmaceuticals LLC
NCT01798121Phase 2Feb 1, 2013INC Research, JHP Pharmaceuticals LLC
NCT01642888Phase 3Sep 1, 2012Karl Bremer Hospital, Cape Town South Africa, Statens Serum Institut
NCT01631266Phase 3Jul 1, 2012Province of Barcelona, Spain, Statens Serum Institut
NCT01689831Phase 2May 1, 2012INC Research, JHP Pharmaceuticals LLC
NCT01242475Phase 2Apr 1, 2011Statens Serum Institut, University of London
NCT01241188Phase 2Apr 1, 2011Statens Serum Institut, University of Cape Town
NCT00716989N/ANov 1, 2008University of Lyon
NCT00078247Phase 3Oct 1, 2004Case Western Reserve University, Makerere University, National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (31)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Statens Serum InstitutAcademic/Hospital5522011
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.For profit3322014
Assiut UniversityAcademic/Hospital3322017
INC ResearchFor profit3012012
JHP Pharmaceuticals LLCFor profit3312012
National Institute of Allergy and Infectious Diseases (NIAID)Government3331999
Fudan UniversityAcademic/Hospital2012014
Huazhong University of Science and TechnologyAcademic/Hospital2022014
Padjadjaran UniversityAcademic/Hospital2222022
People's Liberation Army of ChinaGovernment2012014
Proswell Medical CorporationFor profit2012014
Tianjin UniversityAcademic/Hospital2012014
University of Cape TownAcademic/Hospital2022011
University of LondonAcademic/Hospital2112001
Case Western Reserve UniversityAcademic/Hospital1012004
Centers for Disease Control and Prevention (CDC)Government1012004
ChungHwa Veterans houseAcademic/Hospital1012004
Karl Bremer Hospital, Cape Town South AfricaAcademic/Hospital1012012
Makerere UniversityAcademic/Hospital1012004
National Center for Tuberculosis Problems, KazakhstanGovernment1012013
31 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Par PharmaceuticalsFor profitNDA2Apr 20, 1998
Par PharmaceuticalsFor profitNDAApr 20, 1998
Sanofi-AventisFor profitNDA2Feb 24, 2000