NYSE — Healthcare: Manufacturing, Drug Manufacturers - General: Pharmaceutical Preparations
www.abbvie.comAbbVie's Phase 3 open-label trial (NCT04166058) evaluating the long-term safety of linaclotide in pediatric patients aged 6-17 with functional constipation (FC) or irritable bowel syndrome with constipation (IBS-C) is expected to complete on June 5, 2025. The study enrolled 389 participants who previously completed related linaclotide studies. Linaclotide is a guanylate cyclase-C agonist used to treat constipation-related disorders. The trial's completion may inform future pediatric indications and regulatory submissions.
trial completionThe 250 women entrepreneurs selected for The Confidence Project's Boostcamp will be announced, providing them with mentorship and resources.
otherAbbVie is conducting a Phase 2 clinical trial evaluating linaclotide for functional constipation in children aged 6 months to under 2 years. The study, enrolling up to 30 participants, assesses safety and efficacy versus placebo, with completion expected by September 1, 2025. Linaclotide is already approved for adult use and is being developed for pediatric indications, addressing an unmet need as no pharmacological therapies are currently approved for this age group.
trial completionAbbVie is expected to complete a Phase 3 clinical trial (NCT04401748) on September 10, 2025, evaluating the combination of venetoclax and azacitidine versus azacitidine plus placebo in adults with newly diagnosed higher-risk myelodysplastic syndrome (MDS). Venetoclax is an investigational BCL-2 inhibitor, while azacitidine is a hypomethylating agent approved for MDS. The study aims to assess efficacy and safety in approximately 531 participants across 220 global sites. Results may inform future regulatory submissions for venetoclax in MDS.
trial completionThe 20 grant recipients from The Confidence Project will be announced, awarding $20,000 each to selected women entrepreneurs.
otherA clinical trial sponsored by Mayo Clinic, with AbbVie involvement, is expected to complete on December 1, 2025. The study evaluates the efficacy of combining disease-targeted virtual reality (VR) therapy with linaclotide in patients with irritable bowel syndrome with constipation (IBS-C). Linaclotide, marketed by AbbVie as Linzess, is a guanylate cyclase-C agonist approved for IBS-C. The trial aims to determine if VR can enhance quality of life and symptom improvement when used alongside linaclotide.
trial completionAbbVie is conducting a global Phase 3, randomized, double-blind, placebo-controlled trial (NCT02993523) evaluating venetoclax in combination with azacitidine versus azacitidine alone in treatment-naïve adults with acute myeloid leukemia (AML) ineligible for standard induction therapy. The study, enrolling 443 participants across approximately 180 sites, is expected to complete on January 23, 2026. Venetoclax is a BCL-2 inhibitor targeting cancer cell survival, and azacitidine is a hypomethylating agent. The trial's outcome may impact future AML treatment protocols.
trial completionAbbVie is conducting the Pivotal 1 Study (NCT04704921), a Phase 2b/3 clinical trial evaluating ABBV-RGX-314, a one-time subretinal gene therapy for neovascular age-related macular degeneration (nAMD). The trial, enrolling approximately 540 participants, is expected to complete by May 1, 2026. The primary endpoint is the mean change in best-corrected visual acuity compared to ranibizumab at 54 weeks. ABBV-RGX-314 is designed to provide sustained anti-VEGF therapy via gene delivery, potentially reducing treatment burden for nAMD patients. Trial completion may inform future regulatory submissions.
trial completionThe phase 1/2 clinical trial of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in relapsed or refractory multiple myeloma is expected to complete on May 12, 2026. The study, sponsored by TeneoOne (an AbbVie company), is evaluating safety, pharmacology, and clinical activity in patients who have received at least three prior therapies. TNB-383B is being developed as a potential treatment for patients with limited options due to disease progression.
trial completionA Phase I clinical trial evaluating venetoclax in combination with daunorubicin and cytarabine for treatment-naïve acute myeloid leukemia (AML) patients is expected to complete on June 1, 2026. The study, sponsored by Dana-Farber Cancer Institute, aims to determine the safety and optimal dosing of venetoclax in this setting. Venetoclax, marketed by AbbVie, is already approved for other hematologic malignancies but remains investigational for AML in this combination. The trial's outcome may inform future development and regulatory strategies for venetoclax in AML.
trial completion