相关临床试验
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成立时间
2010
已完成
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- 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.
- 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 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.
- Health Canada launched a new public Clinical Trials Search Portal on July 29, 2026, replacing the former Clinical Trials Database to enhance transparency for authorized Canadian clinical trials. - The accompanying guidance expects sponsors to register trials in a WHO-compliant registry no later than 21 calendar days after first participant enrolment, and to submit summary results within 12 months of primary study completion. - The guidance applies to phase 1–3 drug and natural health product trials and Class II–IV medical device investigational testing, while excluding comparative bioavailability studies, OLIP trials, and phase IV trials. - Although not yet legally binding, the policy-first approach signals Health Canada's direction toward future regulations on clinical trial registration and results disclosure.
- The federal government will build a $267-million medical countermeasures laboratory in Winnipeg, slated to open in 2033 next to the National Microbiology Laboratory. - The facility aims to bridge a critical gap in testing early-stage vaccines, therapeutics, and diagnostic tools against pathogens with pandemic potential. - Experts caution that sustained, decades-long funding for human talent and research—not just a new building—will determine whether the lab succeeds. - A $10.2-million design contract was awarded to Winnipeg's Architecture49 Inc., with design completion expected by 2029 and construction beginning in 2030.
- Canada's federal Pharmaceutical and Life Sciences Sector Task Force released a report on July 24 calling for "deliberate, bold and swift action" to improve pharmaceutical competitiveness, with key recommendations to be implemented within three months. - The report identifies slow drug-pricing negotiations and price-containment efforts as harming Canada's attractiveness as an investment destination, with the pCPA taking roughly 195 days followed by 99 to 219 additional days for provincial formulary decisions. - Recommendations include Health Canada adopting more systematic reliance on trusted foreign regulators for oncology, HIV, antimicrobial, and rare disease drugs, and the CDA redefining value frameworks to recognize innovation. - Health Minister Marjorie Michel and Industry Minister Mélanie Joly welcomed the report, stating the government will carefully consider the recommendations to improve affordable access while strengthening the life sciences sector.
- Health Canada has granted a Notice of Compliance to CLINUVEL's SCENESSE® (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). - SCENESSE® becomes the only treatment for EPP to receive marketing authorization from any regulatory body worldwide, following prior approvals in Europe (2014), the U.S.A. (2019), and Australia (2020). - The drug has been administered over 21,000 times globally, with the longest-treated patients receiving up to 20 years of continuous therapy, demonstrating a proven long-term safety profile. - Five trained and accredited Specialty Centers in Canada are already positioned to treat EPP patients, having previously provided SCENESSE® under special access arrangements.
- AMO Pharma reached agreement with the FDA, MHRA, and Health Canada on the design of a registrational study for AMO-02 (oral tideglusib) in congenital myotonic dystrophy type 1 (cDM1). - The trial will use hospitalization as the primary efficacy endpoint, reflecting the significant burden of this life-threatening rare neuromuscular disorder. - Multiple functional assessments will serve as secondary outcome measures to characterize disease progression and capture the variable clinical features of cDM1. - The company expects to provide an update on study initiation during the third quarter of 2026.
- Health Canada has approved the expansion of Biodexa's registrational Phase 3 Serenta trial for familial adenomatous polyposis (FAP) into Canada, adding three to four new clinical centers. - The double-blind, placebo-controlled trial is currently active across 29 centers in the US and five European countries, with 73 of a planned 168 patients enrolled to date. - eRapa, an oral mTOR inhibitor formulation of rapamycin, targets mTOR overexpression in FAP polyps and has received Orphan Drug Designation in the US. - FAP currently has no approved therapeutic option; standard of care remains active surveillance and life-altering surgical resection of the colon and/or rectum.
