- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Trial completion date, Trial primary completion date, Metastases: Tivozanib + Enzalutamide in Adv Prostate Cancer (clinicaltrials.gov) - Sep 1, 2020 P2, N=5, Active, not recruiting, Completed --> Terminated; Lack of new studies contributing subjects to this study Trial completion date: Jun 2020 --> Jun 2023 | Trial primary completion date: Dec 2019 --> Dec 2022
- |||||||||| CUE-101 / Cue Biopharma, LG Chem
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Aug 24, 2020 P1, N=85, Recruiting, Trial completion date: Jun 2020 --> Jun 2023 | Trial primary completion date: Dec 2019 --> Dec 2022 N=50 --> 85 | Trial completion date: Nov 2022 --> Aug 2023 | Trial primary completion date: Jun 2021 --> Jul 2022
- |||||||||| Follitrope (recombinant human follicle stimulating hormone) / LG Chem
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Observational Study to Develop Dosing Chart (clinicaltrials.gov) - Aug 7, 2020 P=N/A, N=534, Completed, Available data do not support the hypothesis of an association of DPP4i treatment with malignancies, with a possible beneficial effect for colon-rectal cancer. Recruiting --> Completed | N=1000 --> 534 | Trial completion date: Nov 2020 --> Jul 2020 | Trial primary completion date: Nov 2020 --> Jul 2020
- |||||||||| Basalin (insulin glargine biosimilar) / Gan & Lee Pharma, LG Chem, Sandoz
Trial completion, Trial completion date, Trial primary completion date: GLITTER 1: Gan & Lee Insulin Glargine Target Type (1) Evaluating Research (clinicaltrials.gov) - Jul 9, 2020 P3, N=550, Completed, Recruiting --> Completed | N=1000 --> 534 | Trial completion date: Nov 2020 --> Jul 2020 | Trial primary completion date: Nov 2020 --> Jul 2020 Active, not recruiting --> Completed | Trial completion date: Feb 2020 --> Aug 2019 | Trial primary completion date: Feb 2020 --> Aug 2019
- |||||||||| ZemiStatin (gemigliptin/rosuvastatin FDC) / LG Chem, rosuvastatin / Generic mfg., AstraZeneca
Clinical, PK/PD data, Journal: A Fixed-Dose Combination Of Gemigliptin And Rosuvastatin Exhibits Similar Pharmacokinetics, Pharmacodynamics, And Safety Compared To That Of A Loose Combination In Healthy Subjects. (Pubmed Central) - Jul 8, 2020 PK, PD, and safety profiles of gemigliptin, its metabolite, and rosuvastatin were similar between FDC and loose combination. The FDC of gemigliptin (50 mg) and rosuvastatin (20 mg) can be used as an alternative to a loose combination, which is expected to improve patient compliance.
- |||||||||| Fotivda (tivozanib) / AVEO, Jazz, Nexavar (sorafenib) / Bayer, Amgen
Clinical, P3 data, Journal: Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. (Pubmed Central) - Jun 28, 2020 P3 The FDC of gemigliptin (50 mg) and rosuvastatin (20 mg) can be used as an alternative to a loose combination, which is expected to improve patient compliance. Our study showed that tivozanib as third-line or fourth-line therapy improved progression-free survival and was better tolerated compared with sorafenib in patients with metastatic renal cell carcinoma.
- |||||||||| Gemiglo (gemigliptin) / Sanofi, LG Chem
Journal: Gemigliptin Attenuates Renal Fibrosis Through Down-Regulation of the NLRP3 Inflammasome. (Pubmed Central) - Jun 26, 2020 Our study showed that tivozanib as third-line or fourth-line therapy improved progression-free survival and was better tolerated compared with sorafenib in patients with metastatic renal cell carcinoma. The present study shows that activation of the NLRP3 inflammasome contributes to UUO-induced renal fibrosis and the renoprotective effect of gemigliptin is associated with attenuation of NLRP3 inflammasome activation.
- |||||||||| tigulixostat (LC350189) / LG Chem
Trial completion, Trial completion date: The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults (clinicaltrials.gov) - Jun 25, 2020 P1, N=24, Completed, The present study shows that activation of the NLRP3 inflammasome contributes to UUO-induced renal fibrosis and the renoprotective effect of gemigliptin is associated with attenuation of NLRP3 inflammasome activation. Not yet recruiting --> Completed | Trial completion date: May 2020 --> Feb 2020
- |||||||||| tigulixostat (LC350189) / LG Chem
Trial completion: Mass Balance Study of [14C]LC350189 in Healthy Volunteers (clinicaltrials.gov) - Jun 25, 2020 P1, N=6, Completed, Not yet recruiting --> Completed | Trial completion date: May 2020 --> Feb 2020 Not yet recruiting --> Completed
- |||||||||| Fotivda (tivozanib) / AVEO, Jazz
Review, Journal: Tivozanib in renal cell carcinoma: a new approach to previously treated disease. (Pubmed Central) - Jun 19, 2020 This review seeks to characterize tivozanib within the context of RCC by highlighting preclinical and early clinical trials alongside the phase III trials in RCC, TIVO-1, and TIVO-3. We also aim to explore further trials of tivozanib, whether in combination with other agents and/or in differing disease settings, while providing insight into the utility of tivozanib as a clinical tool for the management of RCC.
- |||||||||| Fotivda (tivozanib) / Kyowa Kirin, Jazz, LG Chem
Trial completion date, Combination therapy, Metastases: TiNivo study : Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC (clinicaltrials.gov) - Jun 4, 2020 P1/2, N=28, Active, not recruiting, We also aim to explore further trials of tivozanib, whether in combination with other agents and/or in differing disease settings, while providing insight into the utility of tivozanib as a clinical tool for the management of RCC. Trial completion date: Dec 2018 --> Dec 2020
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