CDEK
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sofpironium

Trade name: SOFDRA

Small moleculeapproved

Approved

Jun 18, 2024

Clinical trial activity

8 trials · 1 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
7
Phase 3
3
Phase 4
0

Earliest trial started Feb 1, 2014 (NCT02058264)

Timeline

2010s

  1. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jun 18, 2024

    Botanix Pharmaceuticals — Earliest FDA Approval

  2. Jun 18, 2024

    Botanix Pharmaceuticals — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 18, 2024

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)C[N+]1(C)CC[C@@H](OC(=O)[C@](O)(c2ccccc2)C2CCCC2)C1
Mol. weight
390.5 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • sofpironium
  • sofpironium
  • sofpironium bromide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03948646Phase 3Jun 30, 2019Brickell Biotech, Inc.
NCT03836287Phase 3Jun 30, 2019Brickell Biotech, Inc.
NCT03785587Phase 2Dec 21, 2018Brickell Biotech, Inc.
NCT03627468Phase 3Aug 20, 2018Brickell Biotech, Inc.
NCT03024255Phase 2Dec 1, 2016Brickell Biotech, Inc.
NCT02682238Phase 2Feb 1, 2016Brickell Biotech, Inc.
NCT02336503Phase 2Feb 1, 2015Brickell Biotech, Inc.
NCT02058264Phase 1Feb 1, 2014Brickell Biotech, Inc.
Showing 8 of 8 trials
Page 1 / 1

Organizations

Research & Development (1)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Brickell Biotech, Inc.For profit8832014
1 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Botanix PharmaceuticalsFor profitNDAJun 18, 2024