drugset
Drugs / BIIB091
last change Feb 2026 re-read 9 days ago

BIIB091

also known as [14C]-BIIB091

Small molecule targets BTK via inhibition

Developed for
multiple sclerosis
Investigated by
Biogen

Trials 6

today NCT06640933 · Ph 1 NCT06574828 · Ph 1 NCT06311786 · Ph 1 NCT05798520 · Ph 2 NCT04564612 · Ph 1 NCT03943056 · Ph 1
2020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT06640933 Oct 2024 → Feb 2025 — Biogen Completed No outcome recorded
Phase 1 NCT06574828 Aug 2024 → Mar 2025 — Biogen Completed No outcome recorded
Phase 1 NCT06311786 Apr → May 2024 — Biogen Completed No outcome recorded
Phase 1 NCT04564612 Sep 2020 → Sep 2022 — Biogen Completed No outcome recorded
Phase 1 NCT03943056 May 2019 → Jan 2020 — Biogen Completed No outcome recorded
Phase 21 trial
Phase 2 NCT05798520 Jul 2023 → Feb 2026 multiple sclerosis Biogen Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2020-09-11 Biogen Results New Data at ACTRIMS-ECTRIMS Meeting Showcase Safety and Efficacy of Biogen’s Industry-Leading MS Portfolio biogen.com ↗
Data From a Phase 1 Study of BIIB091 Supports Continued Development for the Treatment of MS

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as BIIB091 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06311786 ↗
5

NCT03943056 ↗

NCT06640933 ↗

NCT05798520 ↗

NCT04564612 ↗

NCT06574828 ↗
Known as [14C]-BIIB091 “Participants will receive a single oral dose of \[14C\]-BIIB091 on Day 1.” NCT06311786 ↗
Action Inhibit “BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor” NCT03943056 ↗
Modality Small molecule — CHEMBL5083772 ↗
Route Oral “single and multiple oral doses of BIIB091” NCT03943056 ↗
Target BTK “BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor” NCT03943056 ↗