Pelubi (pelubiprofen) / Daewon Pharma - LARVOL DELTA

The Efficacy and Safety of Pelubiprofen in the Treatment of Acute Upper Respiratory Tract Infection: A Multicenter, Randomized, Double-Blind, Non-Inferiority Phase III Clinical Trial Compared to Loxoprofen. (PubMed, J Clin Med) - P3 | " Pelubiprofen is not inferior to loxoprofen in reducing fever associated with URTIs and is a safe and effective treatment option. Registration: (ClinicalTrials.gov identifier: NCT01779271)."

Clinical • Head-to-Head • Journal • P3 data • Infectious Disease • Musculoskeletal Pain • Otorhinolaryngology • Pain • Respiratory Diseases

Synergistic attenuation of complete freund's adjuvant-induced inflammation in mice using shinbaro-pelubiprofen: a novel therapeutic complex. (PubMed, Mol Med) - "This combined effect highlights SBR-Pel's potential as an effective treatment for inflammatory diseases driven by heightened macrophage activity, while also minimizing side effects by reducing the Pel dosage."

Journal • Preclinical • Infectious Disease • Inflammation • Pain • CD68 • IL10 • MRC1 • TGFB1

Antinociceptive and anti-inflammatory activity of DW-1021, the ionic complex of pelubiprofen and tramadol, in rodents. (PubMed, Biomed Pharmacother) - "Although drugs such as acetaminophen, opioids, and nonsteroidal anti-inflammatory drugs (NSAIDs), are commonly used for pain management, the side effects of these drugs such as hepatotoxicity, nephrotoxicity, nausea, and vomiting, can not be neglected. In the carrageenan-induced rats, DW-1021 had a more potent effect on reducing paw inflammation (paw volume, width, and thickness) via the suppression of PGE production than tramadol, but less than that of pelubiprofen. Taken together, our results suggest that the administration of DW-1021, a combination of pelubiprofen and tramadol, exerted a potent effect and can be used as a potential therapeutic agent for relieving pain and inflammation."

Journal • Preclinical • Hepatology • Inflammation • Pain

Pharmacokinetic and Pharmacodynamic Characteristics of Pelubiprofen Tromethamine vs. Pelubiprofen in Healthy Subjects. (PubMed, Pharmaceutics) - "The maximum cyclooxygenase-2 inhibitory effect of 25 mg of pelubiprofen tromethamine was approximately 98% compared to the reference, showing no significant pharmacodynamic variation. It is thus predicted that 25 mg of pelubiprofen tromethamine would show no clinically significant discrepancies in clinical analgesic and antipyretic effects from 30 mg of pelubiprofen."

Journal • PK/PD data • Gastrointestinal Disorder • Pain

Russia OKs Daewon's non-steroidal anti-inflammatory drug (Korea Biomedical Review) - "Daewon Pharmaceutical said it has won approval from the Ministry of Health of the Russian Federation for Pelubi, its non-steroidal anti-inflammatory drug (NSAID), and will launch it under the brand name Pelubio. Daewon will produce Pelubi at its plant in Gyeonggi Province and export it to Russia."

Non-US regulatory • Back Pain • Central Neuropathic Pain • CNS Disorders • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatoid Arthritis

Development of Pelubiprofen Tromethamine with Improved Gastrointestinal Safety and Absorption. (PubMed, Pharmaceutics) - "The pharmacokinetic study of the PEL-T powder showed higher maximum plasma concentration (C) and area under the plasma concentration-time curve from 0 h to the last time point (AUC) than those of the PEL powder. Taken together, our data suggest that PEL-T is a recommendable candidate with enhanced gastrointestinal safety and better absorption compared with commercial PEL."

Clinical • Journal • Gastrointestinal Disorder

XXYLT1 methylation contributes to the occurrence of lung adenocarcinoma: Methylation and lung adenocarcinoma. (PubMed, Medicine (Baltimore)) - "Our results suggested that methylation of XXYLT1 may have significance in the pathogenesis of lung adenocarcinoma."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial. (PubMed, PLoS One) - "Pelubiprofen CR 90 mg is as effective as aceclofenac 200 mg with reduced adverse events for the treatment of symptomatic knee osteoarthritis."

Clinical • Head-to-Head • Journal • P4 data • Immunology • Osteoarthritis • Pain • Rheumatology

Transcutaneous Electrical Nerve Stimulator to Improve Blood Glucose Control in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P=N/A; N=160; Active, not recruiting; Sponsor: Taiwan Resonant Waves Research Corporation; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Dec 2019 ➔ Nov 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea (clinicaltrials.gov) - P3; N=120; Not yet recruiting; Sponsor: Daewon Pharmaceutical Co., Ltd.

Clinical • New P3 trial

Machine learning in prediction of genetic risk of nonsyndromic oral clefts in the Brazilian population. (PubMed, Clin Oral Investig) - "Although validation is necessary, this genetic panel can be useful in the near future to assist in NSCL ± P genetic counseling."

Clinical • Journal • MTHFR

[VIRTUAL] Genome-wide association analysis in host genetic characteristics of progression to high-grade cervical intraepithelial neoplasia or higher for women with human papillomavirus infection and normal cytology. (ASCO 2020) - "A risk-predictive panel of 8 SNPs rs3097662, rs35979982, rs7763822, rs4282438, rs3128927, rs7759943, rs213194, rs17835649 which were significant in the replication (p < 0.05) was used to train models for disease risk prediction using the combination of GWAS and verification sets... Two risk-predictive SNP panels including 7 SNPs with hr- or lr-HPV groups can assist risk stratification among HPV-positive/ normal cytology women. These panels could be further tested in other ethnic populations. Research Funding: Supported by grants from Chang Gung Medical Foundation (OMRPG3B0041, CMRPG371151-3, CMRPG380731, CMRPG391451, and CRRPG3D0021/2/3), and the Ministry of Health and Welfare-Taiwan (DOHW105-TDU-B-212-113003, MOHW106-TDU-B-212-113005, and MOHW107-TDU-B-212-11"

Clinical • Cervical Cancer • Gynecologic Cancers • Immunology • Infectious Disease • Mood Disorders • Oncology

Identification of nsSNPs of transcription factor E2F1 predisposing individuals to lung cancer and head and neck cancer. (PubMed, Mutat Res) - "Statistical analysis showed that the mutant alleles/genotypes of rs3213172 (R252H) were found to increase ∼ 2-5 fold risk of LC and HNC in all the genetic models. These results suggest that the rs3213172C/T polymorphism of the E2F1 gene could be used as an effective biomarker for genetic susceptibility to LC and HNC in our population."

Clinical • Journal • Head and Neck Cancer • Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • E2F1

Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection (clinicaltrials.gov) - P3; N=183; Completed; Sponsor: Daewon Pharmaceutical Co., Ltd.; Recruiting ➔ Completed; Trial primary completion date: Jun 2016 ➔ Mar 2016

Trial completion • Trial primary completion date • Biosimilar • Immunology

Transcutaneous Electrical Nerve Stimulator to Improve Blood Glucose Control in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P=N/A; N=160; Recruiting; Sponsor: Taiwan Resonant Waves Research Corporation; Trial completion date: Jun 2019 ➔ Dec 2019; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date

Association of genetic polymorphisms in genes involved in Ara-C and dNTP metabolism pathway with chemosensitivity and prognosis of adult acute myeloid leukemia (AML). (PubMed, J Transl Med) - "Data from our study demonstrated that SNPs in Ara-C and dNTP metabolic pathway predict chemosensitivity and prognosis of AML patients in China."

Clinical • Journal

Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury (clinicaltrials.gov) - P3; N=94; Recruiting; Sponsor: Daewon Pharmaceutical Co., Ltd.

Clinical • New P3 trial