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mitapivat

Trade name: Pyrukynd

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 17, 2022

Clinical trial activity

27 trials · 6 clinical orgs · 2 marketing orgs

Phase 1
13
Phase 2
13
Phase 3
8
Phase 4
1

Earliest trial started Mar 1, 2014 (NCT02108106)

Timeline

2010s

  1. Jan 1, 2014

    Agios Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Agios Pharmaceuticals, Inc. — Earliest Phase 2 Sponsor(trial)

  3. Mar 24, 2015

    Orphan Drug Designation

  4. Jan 1, 2018

    Agios Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)

2020s

  1. Feb 17, 2022

    Servier — Earliest FDA Approval

  2. Feb 17, 2022

    Agios Pharmaceuticals, Inc. — Marketing Organization

  3. Feb 17, 2022

    Servier — NDA Secondary Org

  4. Feb 17, 2022

    Servier — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackFeb 17, 2022

Chemistry & pharmacology

Loading structure…

SMILES

O.O.O.O=C(c1ccc(NS(=O)(=O)c2cccc3cccnc23)cc1)N1CCN(CC2CC2)CC1.O=C(c1ccc(NS(=O)(=O)c2cccc3cccnc23)cc1)N1CCN(CC2CC2)CC1.O=S(=O)(O)O
Mol. weight
1053.25 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • ag-348

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07055243Phase 2Jun 26, 2025Agios Pharmaceuticals, Inc., University of Toronto
NCT06286046Phase 2Nov 30, 2024Agios Pharmaceuticals, Inc.
NCT06648824Phase 1Oct 31, 2024Agios Pharmaceuticals, Inc.
NCT05935202Phase 2Dec 21, 2023EuroBloodNet Association, Hôpital Saint Louis, University of Copenhagen
NCT05777993Phase 4Jul 5, 2023Agios Pharmaceuticals, Inc.
NCT05610657Phase 1Dec 31, 2022Agios Pharmaceuticals, Inc.
NCT05175105Phase 3Jun 6, 2022Agios Pharmaceuticals, Inc.
NCT05144256Phase 3Mar 1, 2022Agios Pharmaceuticals, Inc.
NCT05031780Phase 2/Phase 3 (Phase 3)Dec 31, 2021Agios Pharmaceuticals, Inc.
NCT04770779Phase 3Nov 30, 2021Agios Pharmaceuticals, Inc.
NCT04770753Phase 3Nov 30, 2021Agios Pharmaceuticals, Inc.
NCT04696393Phase 1Jan 6, 2021Agios Pharmaceuticals, Inc.
NCT04610866Phase 1/Phase 2 (Phase 2)Dec 9, 2020National Heart, Lung, and Blood Institute (NHLBI)
NCT04565678Phase 1Sep 21, 2020Agios Pharmaceuticals, Inc.
NCT04472832Phase 1Jun 17, 2020Agios Pharmaceuticals, Inc.
NCT04000165Phase 1Jul 5, 2019National Heart, Lung, and Blood Institute (NHLBI)
NCT03991312Phase 1Jun 20, 2019Agios Pharmaceuticals, Inc.
NCT03853798Phase 3Mar 21, 2019Agios Pharmaceuticals, Inc.
NCT03692052Phase 2Nov 30, 2018Agios Pharmaceuticals, Inc.
NCT03548220Phase 3Aug 9, 2018Agios Pharmaceuticals, Inc.
Showing 20 of 27 trials
Page 1 / 2

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Agios Pharmaceuticals, Inc.For profit242342014
National Heart, Lung, and Blood Institute (NHLBI)Government2222019
EuroBloodNet AssociationAcademic/Hospital1112023
Hôpital Saint LouisAcademic/Hospital1012023
University of CopenhagenAcademic/Hospital1012023
University of TorontoAcademic/Hospital1112025
6 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Agios Pharmaceuticals, Inc.For profitMKTGFeb 17, 2022
ServierFor profitNDA2Feb 17, 2022
ServierFor profitNDAFeb 17, 2022