CDEK
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spesolimab

Trade name: Spevigo

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Sep 1, 2022

Clinical trial activity

29 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
7
Phase 2
17
Phase 3
7
Phase 4
2

Earliest trial started Mar 27, 2018 (NCT03482635)

Timeline

2010s

  1. Jan 1, 2018

    Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)

  3. Oct 3, 2018

    Orphan Drug Designation

  4. Jan 1, 2019

    Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)

2020s

  1. Sep 1, 2022

    Boehringer Ingelheim — Earliest FDA Approval

  2. Sep 1, 2022

    Boehringer Ingelheim — Marketing Organization

  3. Sep 1, 2022

    Boehringer Ingelheim — NDA Secondary Org

  4. Sep 1, 2022

    Boehringer Ingelheim — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughSep 1, 2022

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06962839Phase 2Jun 5, 2025Boehringer Ingelheim
NCT06624670Phase 3Jan 15, 2025Boehringer Ingelheim
NCT06655220Phase 1Nov 6, 2024Boehringer Ingelheim
NCT06494774Phase 1Aug 5, 2024Boehringer Ingelheim
NCT06520514Phase 1Jul 30, 2024Boehringer Ingelheim
NCT06241573Phase 2/Phase 3 (Phase 3)Apr 16, 2024Boehringer Ingelheim
NCT06013969Phase 4Oct 11, 2023Boehringer Ingelheim
NCT06092216Phase 4Sep 26, 2023Boehringer Ingelheim, Icahn School of Medicine at Mount Sinai
NCT05965583Phase 1Aug 2, 2023Boehringer Ingelheim
NCT05857878Phase 1Jun 19, 2023Boehringer Ingelheim
NCT05819398Phase 2/Phase 3 (Phase 3)Apr 10, 2023Boehringer Ingelheim
NCT05337592Phase 1Jun 14, 2022Boehringer Ingelheim
NCT05239039Phase 3Mar 15, 2022Boehringer Ingelheim
NCT05200247Phase 3Feb 17, 2022Boehringer Ingelheim
NCT05013385Phase 2Nov 9, 2021Boehringer Ingelheim
NCT04876391Phase 2Jul 27, 2021Boehringer Ingelheim
NCT04762277Phase 2Apr 6, 2021Boehringer Ingelheim
NCT04493424Phase 2Sep 4, 2020Boehringer Ingelheim
NCT04399837Phase 2Jun 4, 2020Boehringer Ingelheim
NCT04362254Phase 2May 15, 2020Boehringer Ingelheim
Showing 20 of 29 trials
Page 1 / 2

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boehringer IngelheimFor profit292842018
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112023
2 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Boehringer IngelheimFor profitMKTGSep 1, 2022
Boehringer IngelheimFor profitNDA2Sep 1, 2022
Boehringer IngelheimFor profitNDASep 1, 2022