As of March 2020, Senhwa Biosciences is evaluating the potential Silmitasertib for the treatment COVID-2019 infections. The company also announced that upon meeting specific criteria, it intends to provide the drug free of charge to any hospitals, physicians or research units that elect to treat COVID-19 patients  .
In April 2019, Senhwa Biosciences initiated and enrolled first patient in a phase I trial to determine the recommended phase II dose (RP2D) and schedule of silmitasertib when administered orally twice daily for 28 consecutive days, in a 4 week (28 days) cycle, in patients with locally advanced or metastatic basal cell carcinoma (BCC) (NCT03897036; CX-4945-07). The trial will also evaluate the preliminary efficacy, safety and tolerability of silmitasertib. The non-randomised, open-label trial will enrol approximately 26 patients in the US   .
In March 2019, Pediatric Brain Tumor Consortium in collaboration with St. Jude Children's Research Hospital and National Cancer Institute (NCI) inititated a phase I/II trial to assess the safety, efficacy, pharmacokinetics and maximum tolerated dosage of silmitasertib in patients with recurrent sonic hedgehog (SHH) medulloblastoma (PBTC-053; NCT03904862). The non-randomised trial will enrol approximately 60 participants in the US. The trial is also funded by NIH grant (No. 5UM1CA081457)  .
In June 2018, Senhwa Biosciences reported that subject to positive results from a planned phase I/II trial, the company may apply for fast track designation for silmitasertib, for the treatment of recurrent medulloblastoma  .
In December 2016, the US FDA granted orphan drug designation to CX 4945 for the treatment of cholangiocarcinoma   .
In June 2014, Senhwa Biosciences initiated a phase Ib/II trial to evaluate the safety and tolerability of silmitasertib, in combination with gemcitabine and cisplatin, compared to gemcitabine and cisplatin alone, in the front-line treatment of patients with cholangiocarcinoma (S4-13-001; NCT02128282). The randomised, open-label trial will enrol approximately 216 patients in the US, South Korea, and Taiwan. Senhwa obtained authorisation from the South Korean Ministry of Food and Drug Safety to conduct the trial in South Korea, in January 2015. Approval to start the trial in Taiwan was granted by the Taiwan Food and Drug Administration, in October 2015. The combination regimen was safe, well tolerated and acted synergistically to display a favourable clinical activity, according to the phase I data released in December 2016      .
In November 2018, the US FDA approved IND application for silmitasertib, for the treatment of basal cell carcinoma  .
Following positive data from preclinical and phase I trials, Cylene planned to advance silmitasertib into randomised phase II combination therapy trials. One of these will be with gemcitabine/carboplatin in ovarian cancer, and another will be with erlotinib in non-small cell lung cancer (NSCLC)    .
As at September 2018, silmitasertib is still in phase I development in the US (Senhwa Biosciences pipeline, September 2018).
A dose-escalating, phase I trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral silmitasertib in patients with relapsed or refractory multiple myeloma was initiated in September 2010 (C4-09-001; NCT01199718). Approximately 22 patients from the US were enrolled   .
In January 2009, a phase I trial in patients with advanced solid tumours, Castleman's disease, or multiple myeloma was initiated in the US (C4-08-001; NCT00891280). It aimed to determine the safety, tolerability, and pharmacokinetics of silmitasertib and to determine dosages for phase II trials. Patients received silmitasertib orally, twice daily   . Interim results for 17 patients have been reported   .
As at June 2018, Stanford University School of Medicine was conducting preclinical development in the treatment of recurrent medulloblastoma  .
Cylene Pharmaceuticals presented data on silmitasertib, at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Berlin, Germany in November 2010. The company presented clinical data as well as investigations into the role that silmitasertib plays in the DNA damage response and epidermal growth factor receptor (EGFR) pathways     .
Results from preclinical studies have been reported     .
in December 2013, Senhwa Biosciences completed a $US17 million Series B round of financing. Part of the proceeds will be used to advance silmitasertib through clinical proof-of-concept studies  .
Cylene closed $US12 million in financing from existing investors in September 2010. These funds will be used to finance existing phase I trials and to conduct a series of randomised phase II trials  .