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Oct 16, 2026Weekly roundupUpdated

AbbVie's CANASA label update and ABBV-253 trial recruitment lead busy week of registry changes

FDA cleared a labeling supplement for CANASA while eight other AbbVie-linked trials across oncology, dermatology, and aesthetics saw status updates.

AbbVie's trial and regulatory records showed a labeling approval, a recruiting oncology study, and several updates across dermatology and pharmacokinetic trials this week.

  • The FDA approved a labeling supplement (submission 31) for CANASA (mesalamine) rectal suppositories, with the approval letter dated October 19, 2026, per the agency's Drugs@FDA record.
  • A Phase 1 first-in-human study of ABBV-253, an investigational drug being developed for the treatment of advanced solid tumors1, is recruiting, with approximately 130 participants to be enrolled at approximately 11 sites worldwide.1
  • AbbVie's Phase 2 trial of co-reconstituted trenibotulinumtoxinE and onabotulinumtoxinA for moderate to severe upper facial lines is recruiting, aiming to enroll 300 participants2 and track the percentage of participants achieving none or mild on the investigator-assessed Allergan Glabellar Lines Severity Scale at Day 72.
  • Two atopic dermatitis trials of upadacitinib versus dupilumab were updated: the Phase 3b/4 "SWITCH-UP" study in adults with inadequate response to dupilumab is active but not recruiting, with 184 participants enrolled3, and the Phase 3 "START UP" pediatric study comparing upadacitinib to dupilumab in children ages 2 to less than 12 is also active not recruiting, with 699 participants enrolled4.
  • AbbVie completed a Phase 1 mass balance study of oral [14C] ABBV-932 in healthy male volunteers, with 8 participants enrolled5.
  • A Phase 1 study of single ascending doses of oral ABBV-1042 in healthy volunteers completed, having enrolled 36 participants6.
  • AbbVie's Phase 1 crossover study comparing a new orally disintegrating tablet of ubrogepant against the immediate-release tablet, enrolling 52 participants7, remains active but not recruiting.
  • A Phase 4 study of risankizumab for refractory perianal fistulizing Crohn's disease, sponsored by Yuki Horio with AbbVie as a collaborator, has not yet begun recruiting and plans to enroll 25 participants8.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.