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deutetrabenazine

Trade name: austedo

Small moleculeapprovedOrphan Drug FDA

Approved

Apr 3, 2017

Deutetrabenazine (trade name Austedo) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease. The drug was developed by Auspex Pharmaceuticals and is being commercialized by Teva Pharmaceuticals. Deutetrabenazine is a deuterated derivative of tetrabenazine. The incorporation of deuterium in place of hydrogen at the sites of primary metabolism results in metabolic clearance being slowed, allowing less frequent dosing and better tolerability. — NCATS

Clinical trial activity

15 trials · 7 clinical orgs · 2 marketing orgs

Phase 1
3
Phase 2
9
Phase 3
11
Phase 4
1

Earliest trial started Jul 1, 2013 (NCT01795859)

Timeline

2010s

  1. Jan 1, 2013

    Teva — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2014

    Earliest Phase 2 Sponsor(trial)

  4. Nov 5, 2014

    Orphan Drug Designation

  5. Apr 3, 2017

    Teva — Earliest FDA Approval

  6. Apr 3, 2017

    Teva — NDA Secondary Org

  7. Apr 3, 2017

    Teva — NDA Organization

2020s

  1. Feb 17, 2023

    Teva — Marketing Organization

  2. Dec 26, 2024

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedApr 3, 2017

Chemistry & pharmacology

Loading structure…

SMILES

[2H]C([2H])([2H])OC1=CC2=C(C=C1OC([2H])([2H])[2H])[C@@H]3CC(=O)[C@@H](CC(C)C)CN3CC2
Mol. weight
323.4596 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • austedo
  • austedo
  • deutetrabenazine
  • deutetrabenazine
  • deutetrabenazine
  • deutetrabenazine
  • deutetrabenazine
  • dutetrabenazine
  • dutetrabenazine
  • sd-809
  • sd-809
  • sd-809

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06997198Phase 4Dec 15, 2025Case Western Reserve University, Teva
NCT04713982Phase 2/Phase 3 (Phase 3)Nov 30, 2021Teva, Vanderbilt University
NCT04301726Phase 1May 1, 2020Fundacion Huntington Puerto Rico
NCT04173260Phase 1/Phase 2 (Phase 2)Jan 31, 2020Teva, University of Pennsylvania
NCT04200352Phase 3Dec 24, 2019Teva
NCT03813238Phase 3Jun 14, 2019Teva
NCT03571256Phase 3Jun 22, 2018Nuvelution TS Pharma, Inc., Teva
NCT03567291Phase 3May 25, 2018Nuvelution TS Pharma, Inc., Teva
NCT03452943Phase 2/Phase 3 (Phase 3)Feb 21, 2018Nuvelution TS Pharma, Inc., Teva
NCT02291861Phase 3Oct 1, 2014Auspex Pharmaceuticals, Teva
NCT02198794Phase 3Oct 1, 2014Auspex Pharmaceuticals, Teva
NCT02674321Phase 1Jul 1, 2014Auspex Pharmaceuticals, Teva
NCT02195700Phase 2/Phase 3 (Phase 3)Jun 1, 2014Auspex Pharmaceuticals, Teva
NCT01897896Phase 3Nov 1, 2013Auspex Pharmaceuticals, Teva
NCT01795859Phase 3Jul 1, 2013Teva
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TevaFor profit14642013
Auspex PharmaceuticalsFor profit5522013
Nuvelution TS Pharma, Inc.For profit3012018
Case Western Reserve UniversityAcademic/Hospital1112025
Fundacion Huntington Puerto RicoAcademic/Hospital1112020
University of PennsylvaniaAcademic/Hospital1112020
Vanderbilt UniversityAcademic/Hospital1112021
7 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGDec 26, 2024
TevaFor profitNDA2Apr 3, 2017
TevaFor profitNDAApr 3, 2017
TevaFor profitMKTGFeb 17, 2023