mazindol

Trade name: sanorex

Small moleculeapproved

Approved

Jun 14, 1973

Mazindol is an amphetamine-like medicine which was developed by Sandoz in 1967 and approved by FDA for the treatment of obesity and Duchenne muscular dystrophy under the names Sanorex and Mazanor. The exact mechanism of action is unknown, but possibly involves the stimulation of beta-adrenergic receptors and inhibition of monoamine reuptake. Both Sanorex and Mazanor were withdrawn from the market by reason other than safety. NLS Pharma now is developing mazindol for Attention Hyperactivity Disorder in adults (phase II). — NCATS

Clinical trial activity

5 trials · 4 clinical orgs · 4 marketing orgs

Phase 1
0
Phase 2
5
Phase 3
1
Phase 4
0

Earliest trial started Sep 1, 1994 (NCT00000277)

Timeline

1970s

  1. Jun 14, 1973

    Sandoz — Earliest FDA Approval

  2. Jun 14, 1973

    Novartis — Marketing Organization

  3. Jun 14, 1973

    Hexim — Marketing Organization

  4. Jun 14, 1973

    Sandoz — NDA Organization

  5. Jun 14, 1973

    Novartis — NDA Secondary Org

1980s

  1. Aug 28, 1980

    American Home Products — NDA Secondary Org

1990s

  1. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 1, 2024

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedJun 14, 1973

Chemistry & pharmacology

Loading structure…

SMILES

OC1(N2CCN=C2C3=C1C=CC=C3)C4=CC=C(Cl)C=C4
Mol. weight
284.74 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Availability
Discontinued

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 42-548
  • mazanor
  • mazanor
  • mazanor
  • mazildene
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindol
  • mazindolo
  • mazindolo
  • mazindolum
  • mazindolum
  • sanorex
  • sanorex
  • sanorex
  • teronac
  • teronac

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05914194Phase 3Jan 15, 2024NLS Pharma Inc.
NCT05055024Phase 2Nov 1, 2021NLS Pharma Inc.
NCT04923594Phase 2Sep 13, 2021NLS Pharma Inc.
NCT02808104Phase 2Aug 1, 2016NLS Pharma Inc.
NCT00000277Phase 2Sep 1, 1994Department of Veteran Affairs, National Institute on Drug Abuse (NIDA), Yale University
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NLS Pharma Inc.For profit4422016
Department of Veteran AffairsGovernment1011994
National Institute on Drug Abuse (NIDA)Government1011994
Yale UniversityAcademic/Hospital1111994
4 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
American Home ProductsFor profitNDA2Aug 28, 1980
HeximFor profitMKTGJun 14, 1973
NovartisFor profitMKTGJun 14, 1973
NovartisFor profitNDA2Jun 14, 1973
SandozFor profitNDAJun 14, 1973