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maralixibat

Trade name: LIVMARLI

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Sep 29, 2021

Clinical trial activity

23 trials · 9 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
19
Phase 3
7
Phase 4
1

Earliest trial started Dec 1, 2006 (NCT00504842)

Timeline

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 2 Sponsor(trial)

  2. Sep 4, 2013

    Orphan Drug Designation

  3. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Sep 29, 2021

    Mirum Pharmaceuticals, Inc. — Earliest FDA Approval

  2. Sep 29, 2021

    Mirum Pharmaceuticals, Inc. — Marketing Organization

  3. Sep 29, 2021

    Mirum Pharmaceuticals, Inc. — NDA Secondary Org

  4. Sep 29, 2021

    Mirum Pharmaceuticals, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughSep 29, 2021

Chemistry & pharmacology

Loading structure…

SMILES

CCCCC1(CCCC)CS(=O)(=O)c2ccc(N(C)C)cc2[C@@H](c2ccc(OCc3ccc(C[N+]45CCN(CC4)CC5)cc3)cc2)[C@H]1O
Mol. weight
674.97 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • lum001
  • mrx-801

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07290257Phase 4Sep 25, 2025Mirum Pharmaceuticals, Inc.
NCT06553768Phase 3Oct 31, 2024Mirum Pharmaceuticals, Inc.
NCT06413368Phase 2/Phase 3 (Phase 3)Jul 1, 2024Children's Hospital Los Angeles
NCT05543174Phase 3Dec 31, 2022Takeda
NCT05543187Phase 3Nov 30, 2022Takeda
NCT04729751Phase 2Sep 9, 2021Mirum Pharmaceuticals, Inc.
NCT04524390Phase 2Dec 1, 2020Mirum Pharmaceuticals, Inc.
NCT04185363Phase 3Jan 7, 2020Mirum Pharmaceuticals, Inc.
NCT04168385Phase 2Dec 31, 2019Mirum Pharmaceuticals, Inc.
NCT03905330Phase 3Jul 31, 2019Mirum Pharmaceuticals, Inc.
NCT03353454Phase 3Oct 31, 2018Shire
NCT02475317Phase 1Jun 1, 2015Shire
NCT02321306Phase 2May 1, 2015Shire
NCT02117713Phase 2Mar 16, 2015Childhood Liver Disease Research and Education Network, Lumena Pharmaceuticals, Shire
NCT02057692Phase 2Nov 1, 2014Childhood Liver Disease Research and Education Network, Shire
NCT02160782Phase 2Sep 1, 2014Lumena Pharmaceuticals, Shire
NCT02061540Phase 2Mar 1, 2014Shire
NCT02057718Phase 2Mar 1, 2014Shire
NCT02047318Phase 2Dec 1, 2013Lumena Pharmaceuticals, Shire
NCT01903460Phase 2Aug 1, 2013Shire
Showing 20 of 23 trials
Page 1 / 2

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit111132013
Mirum Pharmaceuticals, Inc.For profit8842019
Lumena PharmaceuticalsFor profit3012013
Childhood Liver Disease Research and Education NetworkAcademic/Hospital2012014
TakedaFor profit2212022
Children's Hospital Los AngelesAcademic/Hospital1112024
Clinigen, Inc.For profit101—
ImaRx TherapeuticsFor profit1112006
Universidad Autonoma de BarcelonaAcademic/Hospital1012006
9 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Mirum Pharmaceuticals, Inc.For profitMKTGSep 29, 2021
Mirum Pharmaceuticals, Inc.For profitMKTGSep 29, 2021
Mirum Pharmaceuticals, Inc.For profitNDA2Sep 29, 2021
Mirum Pharmaceuticals, Inc.For profitNDASep 29, 2021