Part of Government of Canada
Clinical Trials
4
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2010
Completed
4
100.0%
No approval data available
- Health Canada issued a Notice of Compliance for epcoritamab (Epkinly) plus lenalidomide and rituximab in adults with relapsed or refractory grade 1, 2 or 3a follicular lymphoma after at least one prior systemic line. - The approval rests on the phase 3 EPCORE FL-1 trial, in which the epcoritamab regimen cut the risk of disease progression or death by 79% versus lenalidomide and rituximab alone. - Updated EPCORE FL-1 subgroup data showed an overall response rate of 95% versus 79% and complete response rates of 83% versus 50% for the triplet. - Grade 3 or higher treatment-emergent adverse events were more frequent with the epcoritamab regimen, and discontinuation rates were higher in patients aged 70 years or older.
- Health Canada has cleared Palisade Bio's Clinical Trial Application for ASCENTRA-UC, a global Phase 2 study of PALI-2108 in moderately to severely active ulcerative colitis. - The clearance expands the trial's geographic reach alongside prior US regulatory clearance and supports planned site activation and enrollment in Canada. - The randomized, double-blind, placebo-controlled study will enroll about 204 patients and test once-daily 15 mg and 30 mg doses against placebo. - Palisade expects to begin patient dosing in the second half of 2026, with primary efficacy results from the 12-week induction period in the second half of 2027.
- GSK Canada completed negotiations with the pan-Canadian Pharmaceutical Alliance, producing a Letter of Intent for Blenrep in adults with relapsed or refractory multiple myeloma. - The LOI is a step toward public drug plan coverage, with final reimbursement decisions left to individual provincial and territorial plans and their own review timelines. - Blenrep is the first and only anti-BCMA antibody-drug conjugate for multiple myeloma and was approved by Health Canada in two combination regimens in July 2025.
- Health Canada has granted marketing authorisation to Sandoz Semaglutide, a generic GLP-1 receptor agonist injection referencing Novo Nordisk's Ozempic, for adults with type 2 diabetes. - The approval covers once-weekly subcutaneous dosing in three strengths across two pen presentations, including 0.25 mg and 0.5 mg pens and a 1 mg pen. - Sandoz frames the move as an access milestone in a Canadian GLP-1 market worth an estimated USD 2.6 billion, with nearly 12 million semaglutide injection pens used annually. - The Canadian authorisation follows FDA acceptance of Sandoz's generic tirzepatide applications and Brazilian approval of Owozy (semaglutide), and Sandoz expects no material 2026 contribution from generic semaglutide launches.
- Health Canada has authorized an XFG variant-adapted COMIRNATY vaccine for active immunization against COVID-19 in individuals aged 6 months and older. - The 2026-2027 formula targets the Omicron XFG lineage, aligning with public health recommendations to more closely match currently circulating variants. - Pfizer Canada says it has secured sufficient inventory for federal and provincial vaccination programs, with doses reaching distribution channels in the coming days and weeks.
- Optimi Health plans a Health Canada-authorized Phase 3 trial of synthetic MDMA-assisted therapy for PTSD, expected to begin in 2027 across multiple Canadian sites. - The trial aims to enroll up to 100 veterans and current or former frontline workers, including military personnel, police, paramedics, firefighters and healthcare workers. - Participants will receive synthetic MDMA HCl in two dosage formats during two supervised sessions combining MDMA with psychotherapy, spaced several weeks apart. - The primary efficacy endpoint is change in the Clinician-Administered PTSD Scale (CAPS-5), with the program following a Phase 2 psilocybin trial in major depressive disorder.
- Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. - Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos and Tuzemty, denosumab biosimilars referencing Prolia and Xgeva respectively. - Apotex's Denoza and Biocon's Bosaya and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field. - As of September 2026, Europe had approved 14 ustekinumab and 15 denosumab biosimilars, while the US had approved 8 and 19 respectively.
- Health Canada has accepted for review Knight Therapeutics' New Drug Submission for GEMTESA (vibegron) in overactive bladder, including adult males on pharmacological therapy for benign prostatic hyperplasia. - The submission covers OAB with urge urinary incontinence, urgency and frequency in adults, and the same symptoms plus nocturia in men treated for BPH. - Knight licensed Canadian commercialization rights to GEMTESA, ORGOVYX and MYFEMBREE from Sumitomo Pharma America under exclusive supply and distribution agreements signed in June 2025.
- Health Canada completed its review of a Clinical Trial Amendment for Redsenol-1 Plus and indicated it has no objection to the proposed study. - The amendment sets a revised research framework for the ongoing cancer-related fatigue trial, which began in 2022 and has already produced participant data. - Redsenol-1 Plus is an oral botanical formulation containing sixteen rare ginsenosides and is listed in the NCI Drug Dictionary.
- Health Canada issued Class II Medical Device Licenses for Fujirebio's Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the LUMIPULSE G platform. - The pTau 217 Plasma assay aids in identifying amyloid pathology associated with Alzheimer's disease in patients aged 50 and older with cognitive decline. - The NfL Blood assay quantitatively measures neurofilament light chain, a biomarker of neuro-axonal injury, across a range of neurological conditions. - The approvals build on the already CE-marked IVD versions of both assays, expanding blood-based biomarker access in the Canadian market.
