{"id":"apremilast-modified-release-14","_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"PDE4","explanation":"By inhibiting PDE4, apremilast increases intracellular cyclic adenosine monophosphate (cAMP) levels, which modulates the production of pro-inflammatory and anti-inflammatory mediators. This mechanism helps reduce inflammation in various immune-mediated conditions.","oneSentence":"Inhibits phosphodiesterase-4 (PDE4), reducing inflammatory mediators by increasing intracellular cyclic AMP levels."},"_scrapedAt":"2026-03-28T04:53:58.041Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123599,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"apremilast","brand":"Otezla","company":"Amgen","rationale":"Immediate-release formulation of the same active ingredient"},{"name":"deucravacitinib","brand":"Sotyktu","company":"Bristol Myers Squibb","rationale":"Oral TYK2 inhibitor for similar inflammatory conditions"}],"description":"Apremilast Modified Release 14 is a modified-release formulation of apremilast being developed by Amgen in Phase 1 clinical trials. Apremilast is a phosphodiesterase-4 (PDE4) inhibitor, and this formulation may be designed to improve dosing convenience or pharmacokinetic properties compared to immediate-release versions.","indications":{"approved":[{"status":"investigational","condition":"Unknown indication for this formulation","patientPopulation":null}]},"trialDetails":[{"nctId":"NCT04488081","phase":"PHASE2","title":"I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"QuantumLeap Healthcare Collaborative","startDate":"2020-07-31","conditions":"COVID-19","enrollment":1500},{"nctId":"NCT04590586","phase":"PHASE3","title":"Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients","status":"COMPLETED","sponsor":"Amgen","startDate":"2020-11-24","conditions":"COVID-19","enrollment":515},{"nctId":"NCT02236988","phase":"PHASE1","title":"Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-01-07","conditions":"Healthy Volunteers","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_1","status":"active","brandName":"Apremilast Modified Release 14","genericName":"Apremilast Modified Release 14","companyName":"Amgen","companyId":"amgen","firstApprovalDate":"","aiSummary":"Apremilast Modified Release 14 is a small molecule that inhibits phosphodiesterase 4. It is being studied in clinical trials for conditions including COVID-19 and as a treatment option in addition to standard of care.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}