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aminosalicylic acid

Trade name: Paser

Small moleculeapproved

Approved

Mar 8, 1950

Aminosalicylic acid can refer to any amino derivative of salicylic acid, such as:3-Aminosalicylic acid 4-Aminosalicylic acid 5-Aminosalicylic acid (mesalazine) 6-Aminosalicylic acid — Wikipedia

Clinical trial activity

20 trials · 32 clinical orgs · 12 marketing orgs

Phase 1
3
Phase 2
13
Phase 3
8
Phase 4
2

Earliest trial started Dec 1, 1995 (NCT00004423)

Timeline

1950s

  1. Mar 8, 1950

    Earliest FDA Approval

  2. Mar 8, 1950

    Consolidated Midland — NDA Secondary Org

  3. Nov 18, 1955

    Glenwood Pharmaceuticals — NDA Secondary Org

1970s

  1. Apr 14, 1971

    Hexcel — Marketing Organization

  2. Aug 12, 1975

    Medpointe — Marketing Organization

  3. Jan 17, 1978

    Lannett Company, Inc. — Marketing Organization

1990s

  1. Jun 30, 1994

    Jacobus Pharmaceutical — Marketing Organization

  2. Jun 30, 1994

    EUROCEPT PHARMS — Marketing Organization

  3. Jun 30, 1994

    Adaptis Pharma — Marketing Organization

  4. Jan 1, 1996

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 8, 1950

Chemistry & pharmacology

Loading structure…

SMILES

Nc1ccc(C(=O)O)c(O)c1
Mol. weight
153.14 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 4-amino-2-hydroxybenzoic acid
  • 4-amino-2-hydroxybenzoic acid
  • 4-aminosalicylate
  • 4-aminosalicylate
  • 4-aminosalicylic acid
  • 4-aminosalicylic acid
  • 4-aminosalicylic acid
  • 4-aminosalicylic acid
  • 4-aminosalicylic acid
  • 4-aminosalicylic acid
  • 4-carboxy-3-hydroxyaniline
  • 5-aminosalicylate
  • 5-aminosalicylate
  • aminosalicylate
  • aminosalicylate
  • aminosalicylate potassium
  • aminosalicylate potassium
  • aminosalicylate potassium
  • aminosalicylate sodium
  • aminosalicylate sodium
  • aminosalicylate sodium
  • aminosalicylate sodium
  • aminosalicylic acid
  • aminosalicylic acid
  • aminosalicylic acid
  • aminosalicylic acid
  • aminosalicylic acid
  • aminosalicylic acid
  • aminosalicylic acid
  • aminosalicylic acid
  • aminosalicylic acid resin complex
  • aminosalicylic acid resin complex
  • aminosalicylic acid resin complex
  • aminosalicylic acid resin complex
  • aminosalicylic acid resin complex
  • aminosalicylic acid resin complex
  • aminosalicylic acid resin complex
  • aminosalyle sodium
  • aminosalyle sodium
  • apacil
  • granupas
  • p-aminosalicylic acid
  • p-aminosalicylic acid
  • p-aminosalicylic acid
  • para-amino salicylic acid
  • para-amino salicylic acid
  • para-aminosalicylic acid
  • para-aminosalicylic acid
  • para-aminosalicylic acid
  • para-aminosalicylic acid
  • para-aminosalicylic acid
  • para-aminosalicylic acid
  • parasal
  • parasal
  • parasal
  • parasal sodium
  • parasal sodium
  • pas
  • pas
  • pas
  • paser
  • paser
  • paskalium
  • paskalium
  • p.a.s. sodium
  • p.a.s. sodium
  • potassium aminosalicylate
  • potassium aminosalicylate
  • potassium aminosalicylate
  • potassium aminosalicylate
  • rezipas
  • rezipas
  • sodium aminosalicylate
  • sodium aminosalicylate
  • sodium aminosalicylate
  • sodium aminosalicylate
  • sodium p.a.s.
  • sodium p.a.s.
  • teebacin
  • teebacin
  • teebacin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06081361Phase 3Nov 1, 2023Capital Medical University
NCT03892772Phase 1/Phase 2 (Phase 2)Apr 15, 2019Harvard University
NCT03804931Phase 2/Phase 3 (Phase 3)Jan 20, 2019Guangzhou Medical University
NCT02975570Phase 3Aug 1, 2017Boston University, University of Florida, Westat
NCT03070405Phase 1Oct 1, 2016Inje University
NCT02354014Phase 2May 3, 2016Johnson and Johnson
NCT02683733Phase 3Feb 1, 2016Asian Institute of Gastroenterology, Asian Institutes of Gastroenterology
NCT02665845Phase 3Feb 1, 2016University of Lyon
NCT02365623Phase 2Feb 18, 2015Janssen Pharmaceutica NV, Johnson and Johnson
NCT01320436Phase 3Jul 1, 2011Tel Aviv University
NCT00984568Phase 3Nov 1, 2009Merck
NCT00603733Phase 3Oct 1, 2007Ferring
NCT00495521Phase 2Jun 1, 2007Atlantic Health System, Baylor University, Cedars-Sinai Medical Center, Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USA, Jacobus Pharmaceutical, University of California, San Francisco
NCT00417690Phase 2Jan 1, 2007Charlotte Gastroenterology & Hepatology, PLLC, Icahn School of Medicine at Mount Sinai, Jacobus Pharmaceutical, Technion University, Tel Aviv University, University of Chicago
NCT00167882Phase 4Jul 1, 2005Free University of Amsterdam, University of Amsterdam
NCT00042289Phase 4Mar 1, 2003Boston University, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
NCT00000796N/ANov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
NCT00069498Phase 1Oct 1, 1999National Institute of Allergy and Infectious Diseases (NIAID), University of California, Los Angeles
NCT00004810Phase 2Jun 1, 1996National Center for Research Resources (NCRR), University of Vermont
NCT00004423N/ADec 1, 1995University of Vermont
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (32)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government3331999
Boston UniversityAcademic/Hospital2122003
Jacobus PharmaceuticalFor profit2212007
Johnson and JohnsonFor profit2212015
Tel Aviv UniversityAcademic/Hospital2122007
University of VermontAcademic/Hospital2121995
Asian Institute of GastroenterologyAcademic/Hospital1112016
Asian Institutes of GastroenterologyAcademic/Hospital1012016
Atlantic Health SystemAcademic/Hospital1012007
Baylor UniversityAcademic/Hospital1012007
Capital Medical UniversityAcademic/Hospital1112023
Cedars-Sinai Medical CenterAcademic/Hospital1012007
Charlotte Gastroenterology & Hepatology, PLLCAcademic/Hospital1012007
Children's Center for Digestive Healthcare, LLC, Atlanta, Georgia, USAAcademic/Hospital1012007
FerringFor profit1112007
Free University of AmsterdamAcademic/Hospital1012005
Guangzhou Medical UniversityAcademic/Hospital1112019
Harvard UniversityAcademic/Hospital1112019
Icahn School of Medicine at Mount SinaiAcademic/Hospital1012007
Inje UniversityAcademic/Hospital1112016
32 organizations
Page 1 / 2

Marketing (12)

OrganizationOrg typeRelationshipDate
Adaptis PharmaFor profitMKTGJun 30, 1994
Bristol-Myers SquibbFor profitNDA2—
Century PharmaceuticalsFor profitMKTG—
CibaFor profitNDA—
Consolidated MidlandFor profitNDA2Mar 8, 1950
EUROCEPT PHARMSFor profitMKTGJun 30, 1994
Glenwood PharmaceuticalsFor profitNDA2Nov 18, 1955
HexcelFor profitMKTGApr 14, 1971
Jacobus PharmaceuticalFor profitMKTGJun 30, 1994
Lannett Company, Inc.For profitMKTGJan 17, 1978
MedpointeFor profitMKTGAug 12, 1975
Panray Corp.For profitNDA2—