Clinical Trials
1323
290 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1989
Terminated
42
3.2%
Recruiting
325
24.6%
Suspended
1
0.1%
Withdrawn
17
1.3%
Active, not recruiting
53
4.0%
Completed
516
39.0%
Unknown
131
9.9%
Enrolling By Invitation
4
0.3%
Not yet recruiting
233
17.6%
No approval data available
- A study of 27,741 Korean adults found weight-loss medication users were 2.7 times more likely to report suicidal thoughts than non-users. - Those who regained weight after stopping weight-loss drugs faced a 4.2-fold higher odds of suicidal thoughts compared with non-users. - Weight-loss drug users also showed elevated rates of depression (1.9x) and mental health counseling (2.0x) after adjusting for confounders. - Researchers attribute the findings to both neuropsychiatric drug effects and psychological distress tied to failed weight control, while noting no causal relationship was proven.
- 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.
- Organoid Science received IND approval from Korea's Ministry of Food and Drug Safety for ATORM-C, marking the world's first organoid-based regenerative therapy to enter clinical trials. - The Phase 1 trial will evaluate ATORM-C in Crohn's disease patients with colonic ulcers, using autologous intestinal organoids to regenerate damaged mucosal tissue. - This milestone follows an 8.3 billion won technology transfer from KRIBB to Organoid Science, bringing years of stem cell organoid research into commercial development. - The therapy addresses an unmet medical need for patients with refractory ulcers that don't respond to existing anti-inflammatory treatments.
- Daewoong Pharmaceutical's Bersiporocin received a positive safety recommendation from the third Independent Data Monitoring Committee review, allowing continuation of the global Phase 2 clinical trial for idiopathic pulmonary fibrosis. - The trial has enrolled 94 out of 102 planned patients across Korea and the U.S., representing 92% completion of the target enrollment. - Bersiporocin represents a first-in-class approach by selectively inhibiting prolyl-tRNA synthetase, targeting the root cause of fibrosis rather than just slowing disease progression. - Interim baseline characteristics from 92 patients demonstrate consistency between Korean and U.S. cohorts, supporting the global applicability of the trial design.
- 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.
- Daewoong Pharmaceutical presented interim Phase 2 results for Bersiporocin (DWN12088), a first-in-class oral antifibrotic drug targeting idiopathic pulmonary fibrosis, at the 2025 American Thoracic Society International Conference. - The ongoing randomized, double-blind, placebo-controlled study is enrolling 102 patients across 30 sites in the U.S. and South Korea, with over 50% of participants being Asian, enabling assessment across ethnic subgroups. - Bersiporocin selectively inhibits Prolyl-tRNA Synthetase (PRS) to interrupt collagen biosynthesis and fibrotic cascade progression, representing a novel mechanism of action in IPF treatment. - The drug has received Orphan Drug Designation from both FDA and EMA, plus Fast Track designation from FDA, with 80% of target enrollment completed as of April 2025.
- Huonslab has completed patient enrollment in its pivotal Phase 1 clinical trial of HLB3-002 (Hydizyme™), a recombinant human hyaluronidase, with 243 healthy volunteers across four leading South Korean medical centers. - The randomized, double-blind, placebo-controlled study evaluates both allergenicity through intradermal administration and safety via subcutaneous delivery of the investigational biologic. - The company plans to submit a Biological License Application to South Korea's MFDS by the second half of 2025, representing a significant milestone for its HyDIFFUZE™ platform technology. - HLB3-002 is designed to enable subcutaneous delivery of therapeutics as an alternative to traditional intravenous administration, potentially improving patient convenience and reducing healthcare costs.
- Interim analysis of the ATTENTION trial suggests early treatment with Vemlidy (tenofovir alafenamide) significantly reduces liver-related events in hepatitis B patients. - The study found a 79% lower risk of liver disease-related events in the Vemlidy arm compared to the observation arm (HR=0.21, 99.997% CI 0.01-5.45). - Experts advocate for revising treatment guidelines to include viral load as a key metric, potentially preventing thousands of liver cancer cases annually. - The ATTENTION study highlights the potential for early intervention to reduce healthcare costs and improve patient outcomes in chronic hepatitis B.
- A multi-center, double-blind, randomized trial is underway to compare ROTEM-guided tranexamic acid (TXA) administration with preemptive TXA in cardiovascular surgery patients. - The study aims to determine if ROTEM-guided TXA is non-inferior to preemptive TXA in reducing postoperative blood loss, with recruitment ongoing until December 2024. - The trial will also assess secondary outcomes such as blood transfusion rates, coagulation profiles, thromboembolic complications, and hospital costs. - Findings from this pragmatic trial will inform clinical practice by evaluating the effectiveness of ROTEM-guided TXA in real-world settings.
- A South Korean study suggests fecal microbiota transplants (FMTs) may enhance immunotherapy efficacy in gastrointestinal (GI) cancer patients resistant to anti-PD-1 drugs. - The study found that 46.2% of patients with metastatic solid tumors refractory to nivolumab benefited from FMTs, showing tumor shrinkage in some cases. - Specific bacterial strains, like *Prevotella merdae*, improved FMT effectiveness, while others, such as *Lactobacillus salivarius*, had detrimental impacts. - Researchers emphasize the need for efficient FMT production methods and further clinical trials to integrate FMT into standard cancer treatment.
