Overview of Clinical Trial Approvals – 4th Week of October 2025
During the fourth week of October 2025, the Ministry of Food and Drug Safety (MFDS) approved three new clinical trials in Korea. These newly authorized studies cover therapeutic areas such as infectious diseases, respiratory disorders, and oncology. The week’s approvals demonstrate a balanced landscape—domestic pharmaceutical firms advancing early-stage trials while global sponsors initiate late-phase oncology studies that include Korean sites. This dual momentum further solidifies Korea’s position as a leading hub for global clinical research.
Expansion of Early-Phase Clinical Trials by Domestic Companies
Two of the three approvals were Phase I trials led by domestic pharmaceutical companies, underscoring the continued expansion of Korea’s early-stage research ecosystem. These studies focus on evaluating safety, tolerability, and pharmacokinetic characteristics, marking critical steps in early drug development.
Microbiotics Co., Ltd. initiated a randomized, double-blind, placebo-controlled Phase I trial to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MP101in adult patients with acute Pseudomonas aeruginosa pneumonia. This study aims to explore innovative antibiotic approaches targeting severe bacterial infections, contributing to the development of next-generation respiratory therapeutics.
Myeongmun Pharmaceutical Co., Ltd. received approval to conduct an open-label, randomized, crossover Phase I trial comparing the pharmacokinetics (PK) and safety of MMP-123 and its reformulated version, MMP-123-R, in healthy volunteers under fasting conditions. The study’s design will provide key comparative data to support future strategies for improved formulations and incremental innovation within Korea’s drug development pipeline.
Global Oncology Trial Inclusion in Korea
On the global front, Pharmaceutical Research Associates Korea (PRA Korea) obtained approval for a Phase III multinational trial (ALPACCA study) evaluating Permonertinib as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring rare EGFR P-loop and α-C helix compressing (PACC) mutations.
The study, a randomized, multicenter, open-label trial, compares the efficacy and safety of Permonertinib against Osimertinib or Apatinib, depending on investigator selection. Inclusion of Korean research sites in this pivotal global study highlights the growing trust in Korea’s clinical infrastructure and its contribution to generating high-quality global-standard data. Such participation is expected to play a significant role in global regulatory submissions and future market access strategies.
Insights and Outlook
The fourth week’s approvals exemplify the multi-layered progress of Korea’s clinical research ecosystem. Domestic companies are actively entering the clinical stage with new chemical entities, while multinational sponsors are increasingly integrating Korea into their pivotal late-phase programs.
These trends are underpinned by MFDS’s accelerated and transparent IND review framework, including dedicated review teams and parallel GMP evaluations within 90 days, which enhance both speed and reliability in regulatory processes. This evolving environment not only facilitates faster study initiation but also strengthens Korea’s reputation as a country capable of producing globally credible clinical data.
Conclusion
The MFDS approvals in the fourth week of October 2025 illustrate the synergy between domestic innovation and global collaboration. With growing infrastructure capacity, efficient regulatory pathways, and internationally recognized data quality, Korea continues to reinforce its role as a strategic partner for global pharmaceutical companies pursuing faster and higher-quality clinical development.
| Company Name | Component Name | Clinical Trial Title | Clinical Trial Phase | Development Region | Approval Date |
| Dongkuk Pharmaceutical Co., Ltd. | DKF-460 | "A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of 'DKF-460' and 'DKF-460R' in Healthy Adult Volunteers: Open-Label, Randomized, Fasting, Single-Dose, 2-Group, 2-Period, Crossover Design" | Phase 1 | Domestic Development | 20/10/2025 |
| Medpace Inc. | Acoramidis (AG10) 356 mg Film-Coated Tablet | "A Phase 3, Label-Open, Multicenter Extension Trial of Acoramidis in Newly Diagnosed Patients with Variant Transthyretin Amyloid Cardiomyopathy (ATTR-CM) (ACT-EARLY OLE)" | Phase 3 | Overseas Development | 17/10/2025 |
| Korean Parexel Co., Ltd. | Rebumenib | "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Rebumenib in Combination with Intensive Chemotherapy in Newly Diagnosed Patients with NPM1-Mutated Acute Myeloid Leukemia (AML) (REVEAL-ND NPM1)" | Phase 3 | Overseas Development | 16/10/2025 |
| ICON Clinical Research Korea Ltd. | RO7790121 | "A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with RO7790121 in Patients with Moderate to Severe Active Crohn's Disease" | Phase 3 | Overseas Development | 16/10/2025 |
| STCUBE Co., Ltd. | Nelmastobart | "A Multicenter Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Nelmastobart in Combination with Docetaxel in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Are Refractory or Intolerant to Platinum-Based Chemotherapy and/or Immuno-Oncology Therapy: Adaptive Design" | Phase 2 | Domestic Development | 16/10/2025 |
| Pfizer Korea Ltd. | PF-06651600 | "A Phase 2b Randomized, Double-Blind, 12-Week Placebo-Controlled Clinical Trial with a 12-Week Double-Blind Extension Period to Evaluate the Efficacy, Safety, and Tolerability of Ritlecitinib (PF-06651600) in Adult Subjects with Chronic Spontaneous Urticaria" | Phase 2b | Overseas Development | 15/10/2025 |
| Pfizer Korea Ltd. | PF-07248144 (PF-07220060, PF-07850327) | "A Phase 3, Randomized, Open-Label, Multicenter Clinical Trial of PF-07248144 in Combination with Fulvestrant Compared to Investigator's Choice of Therapy in Adult Subjects with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed on Prior CDK4/6 Inhibitor-Based Therapy" | Phase 3 | Overseas Development | 15/10/2025 |
| Janssen Korea Co., Ltd. | Guselkumab (CNTO 1959) | "A Phase 3, Multicenter, Label-Open, Basket, Long-Term Extension Trial to Evaluate the Safety of Guselkumab in Pediatric Subjects with Crohn's Disease, Ulcerative Colitis, or Pediatric Plaque Psoriasis (TRILOGY)" | Phase 3 | Overseas Development | 15/10/2025 |
| Pharmaceutical Research Associates Korea | XL092 (zanzalintinib) | "A Phase 2/3, Multicenter, Randomized, Open-Label Trial of Zanzalintinib Versus Everolimus in Subjects with Previously Treated, Unresectable, Locally Advanced, or Metastatic Neuroendocrine Tumors" | Phase 2/3 | Overseas Development | 15/10/2025 |
| Korea University Medical Center | Fruzaqla (HMPL-013) | "A Multicenter, Single-Arm, Investigator-Initiated Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Fruquintinib in Combination with Supportive Therapy in Patients with Metastatic Colorectal Cancer Who Have Failed Standard Chemotherapy or Are Untreatable" | IIT | Domestic Development | 15/10/2025 |
| Daewon Pharm Co., Ltd. | DW4421 | "A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW4421 in Patients with Non-Erosive Gastroesophageal Reflux Disease (NERD)" | Phase 3 | Domestic Development | 15/10/2025 |
| Vastera Co., Ltd. | VTB-10 | "A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of VTB-10 in Healthy Adult Volunteers: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose" | Phase 1 | Domestic Development | 15/10/2025 |
| Janssen Korea Co., Ltd. | JNJ-95437446 | "A Phase 1 Clinical Trial of JNJ-95437446 in Subjects with Advanced Solid Tumors" | Phase 1 | Overseas Development | 15/10/2025 |
| Novotech Asia Korea Co., Ltd. | FMC-376 Capsule | "A Phase 1/2 Open-Label Dose Escalation, Dose Expansion, and Cohort Expansion Trial to Evaluate the Safety, PK, and Clinical Activity of FMC-376 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors with KRAS G12C Mutation (PROSPER)" | Phase 1/2 | Overseas Development | 15/10/2025 |
| Yuhan Corporation | YH35324 | "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Lesigercept in Adult Patients with Chronic Spontaneous Urticaria Not Adequately Controlled with H1-Antihistamines" | Phase 2 | Domestic Development | 14/10/2025 |
| Seoul National University Hospital | Ropivacaine Injection | "The Effect of Ultrasound-Guided Transversus Abdominis Plane Block in Pediatric Patients Undergoing Laparoscopic Gastrostomy: A Prospective Randomized Controlled Study" | IIT | Domestic Development | 14/10/2025 |
