Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Fenebrutinib

Overview

  • Priority class: BTK
  • Mechanistic bucket: Bruton's tyrosine kinase pathway program
  • Sponsor: Genentech, Inc.
  • Development focus: Completed or historical urticaria development represented in current raw-source layer
  • Indications represented in current raw sources: Urticaria

Strategy readout

  • Headline: Historical BTK CSU proof-of-concept program, not a visibly expanding current franchise in the local layer.
  • Current strategic read: The local evidence stack shows meaningful phase 2 CSU evidence for fenebrutinib, but the currently visible urticaria program looks more like an important earlier BTK proof point than an actively widening late-stage strategy.
  • Highest visible phase in current registry: Phase 2
  • Strategy confidence in current local layer: Medium

Why this looks like the strategy

  • The program has a clear primary manuscript and completed CT.gov history, but no active recruiting urticaria studies are currently visible in the local registry.
  • This makes fenebrutinib strategically important as precedent and mechanism validation, even if it is not the broadest active BTK urticaria stack here.

What to watch next

  • Whether additional source work shows newer urticaria development activity not yet captured in the current local layer.

Operational study design view

Trial Arms in registry Active dose regimens Total enrollment Per-arm sample size summary
NCT03137069 6 3 134 ClinicalTrials.gov results-section denominators support cohort 1 placebo n=13 and fenebrutinib 200 mg BID n=28, plus cohort 2 placebo n=23, fenebrutinib 50 mg daily n=23, 150 mg daily n=24, and 200 mg twice daily n=23, totaling 134 participants.
NCT03693625 2 1 31 ClinicalTrials.gov results-section denominators support parent-study GDC-0853 n=23 and parent-study placebo n=8, totaling 31 participants.

Study Inventory

Completed / historical studies

Active / recruiting studies

  • None in current registry

Other registry entries

  • None in current registry

Program Results Summary

Trials with source-backed results in the current local layer: 1 of 2

NCT03137069 (Published) - Cohort 2 primary endpoint (UAS7 change at week 8, LS mean difference versus placebo): 200 mg BID -9.5 (95% CI -16.7 to -2.4; significant), 150 mg QD -6.4 (95% CI -13.4 to 0.6; trend), 50 mg QD -0.5 (not significant). - No SAEs in Cohort 2; most common AEs: urticaria (15%), nasopharyngitis (11%), headache (6%). - Sources: PMID 34750553; PMCID PMC8604722

Evidence Coverage

  • CT.gov trials in registry: 2
  • Sponsor artifacts in registry: 0
  • Primary publications in registry: 1
  • Supporting publications in registry: 3
  • Publication status: primary_manuscripts_found
  • Publication summary: One clear primary CSU efficacy manuscript was identified. Remaining hits are mostly reviews, mechanistic/background papers, or search collisions.

Primary publications

  • PMID 34750553 (2021, Nature medicine): Fenebrutinib in H1 antihistamine-refractory chronic spontaneous urticaria: a randomized phase 2 trial.
  • Role: phase_2_core
  • Linked trial IDs: EudraCT 2016-004624-35
  • Local cache: raw/publications/pubmed/markdown/PMID34750553.md

Supporting evidence

  • PMID 29457982: Discovery of GDC-0853: A Potent, Selective, and Noncovalent Bruton's Tyrosine Kinase Inhibitor in Early Clinical Development. (raw/publications/pubmed/markdown/PMID29457982.md)
  • PMID 36420759: Fenebrutinib and BTK inhibition: Unveiling a new target for the treatment of chronic spontaneous urticaria. (raw/publications/pubmed/markdown/PMID36420759.md)
  • PMID 40326848: Biological and target synthetic treatments for chronic spontaneous urticaria: A systematic review and network meta-analysis. (raw/publications/pubmed/markdown/PMID40326848.md)

Interpretation

  • Verified facts: the current v2 registry tracks 2 CT.gov entries for this program and links them conservatively to sponsor and publication evidence where explicit identifiers are available.
  • Interpretation: this program already has enough linked manuscript or registry support for a source-first derived program page, but individual study pages should still be reviewed and enriched over time.
  • Open questions:
  • Unclassified publication PMIDs remain in the search set: 35667749, 38141832, 35175630, 31446134, 35166638, 35569949, 30015639, 31494233, 41270830, 41654334

Provenance

  • Primary source(s):
  • ../inventories/source_registry.json
  • ../inventories/source_registry.md
  • Supporting source(s):
  • ../inventories/ctgov_priority_trials.json
  • ../inventories/publication_priority_curation.json
  • ../inventories/sponsor_priority_sources.json
  • Last verified: 2026-04-08
  • Verification status: Partial

Change Log

  • 2026-04-08: Generated or refreshed this program page from the v2 source registry and local source caches.