ammonium lactate

Trade name: lac-hydrin

Small moleculewithdrawn

Approved

Apr 24, 1985

Ammonium lactate is a compound with formula NH4(C2H4(OH)COO). It is the ammonium salt of lactic acid. It has mild anti-bacterial properties. — Wikipedia

Clinical trial activity

5 trials · 3 clinical orgs · 5 marketing orgs

Phase 1
0
Phase 2
4
Phase 3
4
Phase 4
1

Earliest trial started Jan 1, 2009 (NCT01111123)

Timeline

1980s

  1. Apr 24, 1985

    Sun Pharmaceuticals — Earliest FDA Approval

  2. Apr 24, 1985

    Sun Pharmaceuticals — NDA Organization

  3. Apr 24, 1985

    Sun Pharmaceuticals — NDA Secondary Org

2000s

  1. May 1, 2002

    Padagis Us — Marketing Organization

  2. May 1, 2002

    Perrigo — Marketing Organization

  3. Jun 11, 2002

    Watson Pharmaceuticals — Marketing Organization

  4. Apr 10, 2003

    Taro Pharmaceuticals — Marketing Organization

2010s

  1. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Approval history

  • withdrawnApr 24, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CC(O)C(=O)O.N
Mol. weight
107.11 g/mol
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • ammonium lactate
  • ammonium lactate
  • ammonium lactate
  • ammonium lactate
  • ammonium lactate
  • ammonium lactate
  • ammonium lactate
  • ammonium lactate
  • ammonium lactate
  • ammonium (+-)-lactate
  • ammonium (+-)-lactate
  • bms-186091
  • bms-186091
  • e328
  • e328
  • lac-hydrin
  • lac-hydrin
  • lac-hydrin
  • lactic acid ammonium salt
  • lactic acid ammonium salt

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06444763Phase 3Nov 15, 2024RDC Clinical Pty Ltd
NCT06436781Phase 3Sep 12, 2024RDC Clinical Pty Ltd
NCT06104917Phase 3Nov 30, 2023RDC Clinical Pty Ltd
NCT04127513Phase 3Apr 1, 2017University of Indonesia
NCT01111123Phase 4Jan 1, 2009Icahn School of Medicine at Mount Sinai
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RDC Clinical Pty LtdFor profit3312023
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112009
University of IndonesiaAcademic/Hospital1112017
3 organizations
Page 1 / 1

Marketing (7)

OrganizationOrg typeRelationshipDate
Padagis UsFor profitMKTGMay 1, 2002
PerrigoFor profitMKTGMay 1, 2002
PerrigoFor profitSYNMay 1, 2002
Sun PharmaceuticalsFor profitNDAApr 24, 1985
Sun PharmaceuticalsFor profitNDA2Apr 24, 1985
Taro PharmaceuticalsFor profitMKTGApr 10, 2003
Watson PharmaceuticalsFor profitMKTGJun 11, 2002