Part of Samsung Electronics Co., Ltd.
Clinical Trials
1495
224 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1994
Terminated
32
2.1%
Recruiting
310
20.7%
Suspended
3
0.2%
Withdrawn
28
1.9%
Active, not recruiting
71
4.8%
Unknown
266
17.8%
Completed
632
42.3%
Enrolling By Invitation
9
0.6%
Not yet recruiting
144
9.6%
No approval data available
- Samsung received FDA clearance for a Hearing Aid feature in the Galaxy Buds 3 Pro and Buds 4 Pro, transforming consumer earbuds into over-the-counter hearing aids. - The software-based feature uses a self-administered hearing test and NAL-NL2 fitting formula to amplify sounds for adults 18 and older with perceived mild-to-moderate hearing loss. - The feature will roll out to eligible users in the US and select markets in Q4, positioning Samsung in direct competition with Apple's AirPods Pro hearing health suite. - Samsung developed the feature with the National Acoustic Laboratories and Samsung Medical Center, with validation studies at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
- Seoul National University Hospital, in collaboration with Samsung Medical Center, has been testing personalized radiopharmaceutical therapy for children with treatment-resistant solid tumors since February 2024. - The experimental treatment acts like a "radiation missile," combining a radioactive isotope with a molecule that binds to cancer cells to deliver radiation directly to tumors. - Since 2024, nine treatment rounds have been administered to five children with returned or treatment-resistant solid tumors, with no disease progression and stable patient conditions reported. - The Lee Kun-Hee Foundation-funded initiative covers treatment costs, sparing families nearly 10 million won per session, and establishes a pathway for bringing this therapy to pediatric patients in Korea.
- Rapid whole-genome sequencing (Rapid WGS) completes genetic diagnosis in critically ill newborns in an average of 5.5 days, compared with 4–6 weeks for conventional testing. - A genetic cause was identified in 40% of critically ill newborns, and 41% of infant deaths are associated with genetic diseases, underscoring the urgency of early diagnosis. - Korea's National Institute of Health expanded the program from a single-center pilot in 2024 to 12 institutions in 2026, projecting benefits for more than 200 families within two years. - Preliminary analyses indicate Rapid WGS shortens hospital stays and reduces medical costs, with clinicians advocating for nationwide rollout and national health insurance coverage.
- AimedBio invested 2 billion won ($1.5 million) in Galaxy, an AI protein design company, to jointly develop brain-blood barrier-penetrating antibody drugs for brain diseases. - Galaxy will use its proprietary AI platform to design BBB-penetrating proteins from scratch, while AimedBio will handle validation and antibody development stages. - This marks the first strategic biotech investment for Galaxy and represents the emerging trend of Korean ADC companies partnering with AI antibody design firms. - The collaboration reflects the industry's shift toward precision antibody design as a key differentiator for ADC efficacy and safety.
- GI Innovation received approval from Korea's MFDS to conduct a Phase 2 clinical trial evaluating GI-102 in combination with Keytruda for treatment-naive metastatic melanoma patients. - The company was selected for an oral presentation of Phase 1 data for GI-101A at ASCO 2026, a distinction reserved for high-priority studies chosen from thousands of global submissions. - The Phase 2 trial will be conducted at world-renowned cancer centers including Mayo Clinic, MD Anderson, and Memorial Sloan Kettering to compare combination therapy against Keytruda monotherapy. - GI-102 was selected for Korea's Gilzabi program, providing dedicated support and fast-track review opportunities for innovative drug commercialization.
- The SMART-DECISION trial demonstrated that discontinuing beta-blockers 1 year after heart attack was noninferior to continued use in stable patients without heart failure. - The randomized trial included 2,540 patients and found the primary endpoint occurred in 7.2% of discontinuation group versus 9% of continuation group over 3.1 years median follow-up. - This represents the first randomized study to support beta-blocker discontinuation in post-MI patients without left ventricular systolic dysfunction or heart failure. - The findings may enable shared decision-making for stable patients experiencing beta-blocker side effects like fatigue, dizziness, or hypotension.
- Extended 5-year follow-up from the RENOVATE-COMPLEX-PCI trial confirms that intravascular imaging guidance maintains its clinical advantage over angiographic guidance for complex coronary lesions. - The study demonstrated a sustained 32% reduction in target-vessel failure and 32% reduction in cardiac death or target-vessel MI with intravascular imaging compared to angiography alone. - Benefits were most pronounced in chronic total occlusion and diffuse long lesions, with most advantages occurring within the first 2 years and no late catch-up phenomenon observed. - Despite growing evidence and guideline support, adoption barriers including cost, reimbursement, and operator familiarity continue to limit widespread use of intravascular imaging.
- The phase 3 LEAP-014 trial demonstrated that adding lenvatinib to pembrolizumab plus chemotherapy did not significantly improve overall survival compared to pembrolizumab plus chemotherapy alone in patients with metastatic esophageal squamous cell carcinoma. - Median overall survival was 17.6 months with the lenvatinib combination versus 15.5 months with the control regimen, failing to reach statistical significance with a hazard ratio of 0.92. - Despite higher response rates in the lenvatinib arm (62.2% vs 54.8%), the addition of lenvatinib increased treatment-related toxicity without meaningful survival benefit. - The results were consistent across prespecified subgroups including patients with high PD-L1 expression, suggesting limited clinical utility for this triple combination approach.
- MedPacto's Vactosertib demonstrated a 36.4% objective response rate in Phase 1 osteosarcoma trials, including one complete remission case, representing more than three times the efficacy of existing treatments. - The company has expanded its Phase 2 clinical trial to six major Korean hospitals and received compassionate use requests from prominent US medical institutions including Johns Hopkins and Stanford. - Vactosertib has received orphan drug designation in the US and Europe, along with FDA Fast Track designation, with Breakthrough Therapy designation discussions ongoing.
- Liminatus Pharma's IBA101, a second-generation CD47 inhibitor, demonstrated strong safety profile in primate studies with no observed anemia or thrombocytopenia at doses up to 100 mg/kg/week. - The company plans to initiate Phase 1 trials in early 2027 through strategic collaboration with Professor Se-Hoon Lee at Samsung Medical Center in Seoul, Korea. - IBA101 is engineered to avoid red blood cell and platelet binding, addressing the severe cytopenia issues that halted earlier CD47 programs from Gilead and Pfizer. - Preclinical combination studies with PD-1/PD-L1 inhibitors showed complete tumor regression in mouse models, positioning IBA101 for the post-patent checkpoint inhibitor market.
