phenylpropanolamine

Trade name: Propadrine

Small moleculewithdrawn

Approved

Jan 4, 1984

(+)-Phenylpropanolamine is an enantiomer of propanolamine. The substance has low adrenergic activity and exerts measurable physiological effect only at high doses, which were lethal to experimental animals tested. Phenylpropanolamine belongs to the sympathomimetic amine class of drugs and is structurally related to ephedrine. The effects of phenylpropanolamine are largely the result of alpha-adrenergic agonist activity resulting from both direct stimulation of adrenergic receptors and release of neuronal norepinephrine. Phenylpropanolamine containing products has been withdrawn by FDA due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. — NCATS

Clinical trial activity

5 trials · 4 clinical orgs · 4 marketing orgs

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

Earliest trial started Jul 1, 2013 (NCT01895400)

Timeline

1930s

  1. Jun 1, 1938

    Evidence of US Marketing

1980s

  1. Jan 4, 1984

    UCB — Earliest FDA Approval

  2. Jan 4, 1984

    UCB — NDA Secondary Org

  3. Jan 4, 1984

    UCB — NDA Organization

  4. Apr 23, 1985

    Graham Dm — NDA Secondary Org

2000s

  1. Sep 29, 2000

    Alpharma — Marketing Organization

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Combination products

Approval history

  • withdrawnJan 4, 1984
  • approvedJun 1, 1938

Chemistry & pharmacology

Loading structure…

SMILES

OS(O)(=O)=O.C[C@H](N)[C@H](O)C1=CC=CC=C1.C[C@H](N)[C@H](O)C2=CC=CC=C2
Mol. weight
400.49 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 2-amino-1-phenylpropan-1-ol
  • 2-amino-1-phenylpropan-1-ol
  • dexatrim
  • dexatrim
  • dimotapp
  • dimotapp l.a.
  • eskornade
  • eskornade
  • fenilpropanolamina
  • fenilpropanolamina
  • norephedrin
  • norephedrin
  • norephedrine
  • norephedrine
  • norephedrine
  • norephedrine hcl
  • norephedrine hcl
  • phenylpropanolamin
  • phenylpropanolamin
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • phenylpropanolamine
  • (+/-)-phenylpropanolamine
  • phénylpropanolamine
  • phénylpropanolamine
  • phenylpropanolamine chloride
  • phenylpropanolamine chloride
  • phenylpropanolamine hcl
  • phenylpropanolamine hcl
  • phenylpropanolamine hcl
  • phenylpropanolamine hydrochloride
  • phenylpropanolamine hydrochloride
  • phenylpropanolamine hydrochloride
  • phenylpropanolamine polistirex
  • phenylpropanolamine polistirex
  • phenylpropanolaminum
  • phenylpropanolaminum
  • p-hydroxyamphetamine
  • p-hydroxyamphetamine
  • ppa
  • procol
  • procol
  • propadrine
  • propadrine
  • propadrine
  • propagest
  • propagest
  • renexin
  • sine-off
  • sine-off
  • triogesic
  • triominic
  • β-hydroxyamphetamine
  • β-hydroxyamphetamine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05445895Phase 4Oct 31, 2022SK Chemicals
NCT05906199Phase 4Jul 28, 2021SK Chemicals
NCT03318276Phase 3Feb 20, 2017SK Chemicals, Yonsei University
NCT02625714Phase 1Jun 1, 2015Dong-A University, SK Chemicals
NCT01895400Phase 3Jul 1, 2013SK Chemicals, University of Ulsan
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SK ChemicalsFor profit5432013
Dong-A UniversityAcademic/Hospital1012015
University of UlsanAcademic/Hospital1112013
Yonsei UniversityAcademic/Hospital1012017
4 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
AlpharmaFor profitMKTGSep 29, 2000
Graham DmFor profitNDA2Apr 23, 1985
NovartisFor profitNDA2
UCBFor profitNDA2Jan 4, 1984
UCBFor profitNDAJan 4, 1984