{"id":"cg100649","safety":{"commonSideEffects":[]},"_chembl":null,"_fixedAt":"2026-03-30T13:49:50.019831","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cathepsin S is a cysteine protease involved in antigen processing and immune regulation. By inhibiting cathepsin S, CG100649 suppresses pathogenic immune responses and reduces inflammation in autoimmune and inflammatory conditions. This mechanism is particularly relevant in diseases driven by aberrant T-cell and B-cell activation.","oneSentence":"CG100649 is a selective inhibitor of cathepsin S that reduces inflammatory responses by modulating immune cell activation and antigen presentation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:05:27.091Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Atopic dermatitis"},{"name":"Other autoimmune and inflammatory conditions"}]},"_fixedFields":["pubmed(10)","modality→Small Molecule"],"trialDetails":[{"nctId":"NCT06590714","phase":"NA","title":"Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.","status":"RECRUITING","sponsor":"Eulji University Hospital","startDate":"2024-08-23","conditions":"Rotator Cuff Tear","enrollment":150},{"nctId":"NCT01154764","phase":"PHASE1","title":"Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649","status":"COMPLETED","sponsor":"CrystalGenomics, Inc.","startDate":"2009-10","conditions":"Healthy","enrollment":28},{"nctId":"NCT01765296","phase":"PHASE3","title":"Phase III Study of CG100649 in Osteoarthritis Patients","status":"COMPLETED","sponsor":"CrystalGenomics, Inc.","startDate":"2013-03","conditions":"Localized Primary Osteoarthritis of Hip, Localized Primary Osteoarthritis of Knee","enrollment":362},{"nctId":"NCT01341405","phase":"PHASE2","title":"Study of CG100649 Versus Celecoxib in Osteoarthritis Patients","status":"COMPLETED","sponsor":"CrystalGenomics, Inc.","startDate":"2011-04","conditions":"Osteoarthritis","enrollment":125},{"nctId":"NCT05370716","phase":"PHASE1","title":"Drug-Drug Interaction Study of \"CG-651\" in Healthy Volunteer","status":"COMPLETED","sponsor":"CrystalGenomics, Inc.","startDate":"2019-11-11","conditions":"Healthy","enrollment":47},{"nctId":"NCT03775629","phase":"PHASE1","title":"Drug-Drug Interaction Study of \"CG100650\" in Healthy Volunteers","status":"COMPLETED","sponsor":"CrystalGenomics, Inc.","startDate":"2018-12-01","conditions":"Healthy","enrollment":41},{"nctId":"NCT01154790","phase":"PHASE1","title":"Phase I Study on Multiple Oral Dosing of CG100649","status":"COMPLETED","sponsor":"CrystalGenomics, Inc.","startDate":"2010-06","conditions":"Healthy","enrollment":120},{"nctId":"NCT00780325","phase":"PHASE1","title":"Effects of Dual Cyclooxygenase-2 and Carbonic Anhydrase Inhibition","status":"TERMINATED","sponsor":"University of Pennsylvania","startDate":"2008-10","conditions":"Healthy Volunteers","enrollment":26},{"nctId":"NCT00530452","phase":"PHASE2","title":"Phase II Study of CG100649 for Primary Osteoarthritis in Male Subjects","status":"UNKNOWN","sponsor":"CrystalGenomics, Inc.","startDate":"2007-10","conditions":"Osteoarthritis, Knee, Osteoarthritis, Hip","enrollment":240}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":10,"recentPublications":[{"date":"2025 Oct","pmid":"41100334","title":"Review of Safety and Efficacy of Polmacoxib: A Novel Dual Inhibitor of Cyclo-oxygenase 2 and Carbonic Anhydrase in Osteoarthritis and Acute Painful Conditions.","journal":"The Journal of the Association of Physicians of India"},{"date":"2016 Sep 9","pmid":"27475498","title":"Structural insight into the inhibition of carbonic anhydrase by the COX-2-selective inhibitor polmacoxib (CG100649).","journal":"Biochemical and biophysical research communications"},{"date":"2015","pmid":"26095375","title":"Understanding the Dual Inhibition of COX-2 and Carbonic Anhydrase-II by Celecoxib and CG100649 Using Density Functional Theory Calculations and other Molecular Modelling Approaches.","journal":"Protein and peptide letters"},{"date":"2015 Apr","pmid":"25672292","title":"Evaluation of preventive and therapeutic activity of novel non-steroidal anti-inflammatory drug, CG100649, in colon cancer: Increased expression of TNF-related apoptosis-inducing ligand receptors enhance the apoptotic response to combination treatment with TRAIL.","journal":"Oncology reports"},{"date":"2015 Jan 1","pmid":"25097102","title":"Pharmacokinetic, pharmacodynamic, and safety/tolerability profiles of CG100649, a novel COX-2 inhibitor: results of a phase i, randomized, multiple-dose study in healthy Korean men and women.","journal":"Clinical therapeutics"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CG100649 2mg","CG100649 4mg"],"phase":"phase_3","status":"active","brandName":"CG100649","genericName":"CG100649","companyName":"CrystalGenomics, Inc.","companyId":"crystalgenomics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CG100649 is a selective inhibitor of cathepsin S that reduces inflammatory responses by modulating immune cell activation and antigen presentation. Used for Atopic dermatitis, Other autoimmune and inflammatory conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}