{"entity":{"id":"deutenzalutamide","kind":"drug","name":"Deutenzalutamide","aka":["HC-1119","HC1119","海纳安","氘恩扎鲁胺软胶囊"],"tldr":"Deutenzalutamide is a hormone-blocking capsule from Hinova Pharmaceuticals, a modified form of enzalutamide, approved in China in 2025 for prostate cancer that has spread and stopped responding to hormone therapy.","summary":"Deutenzalutamide (HC-1119, HC1119, 海纳安) is a small molecule (oral soft capsule), deuterated androgen receptor antagonist from Hinova Pharmaceuticals. A deuterated form of enzalutamide, a second-generation androgen receptor antagonist; in preclinical models it had a lower metabolic rate, higher plasma exposure and lower brain exposure than enzalutamide at equivalent doses. Its furthest stage is approval, for metastatic castration-resistant prostate cancer. ClinicalTrials.gov registers it in 5 studies linked below. Approved by China's NMPA on 29 May 2025 for metastatic castration-resistant prostate cancer (Hinova English pipeline page); added to China's national reimbursement drug list in December 2025 (Hinova Chinese pipeline page). No approval elsewhere in sources read; the global phase 3 vs enzalutamide (NCT03850795, Hinova USA) is terminated.","status":"approved","asOf":"2026-11-03","links":[{"label":"Hinova Pharmaceuticals: hinovapharma.com","url":"https://www.hinovapharma.com/en/chanpinxianguan.html"},{"label":"Hinova Pharmaceuticals: hinovapharma.com","url":"https://www.hinovapharma.com/en/chanpinxianguan.html"},{"label":"Hinova Pharmaceuticals: hinovapharma.com","url":"https://www.hinovapharma.com/chanpinxianguan.html"},{"label":"ClinicalTrials.gov: trials of HC-1119","url":"https://clinicaltrials.gov/search?intr=HC-1119"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate-mcrpc"],"sections":[],"technologies":[],"targets":["androgen-receptor"],"drugs":[],"companies":["hinova-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03851640","nct03850795","nct03774056","nct03778047","nct03776968"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"HC-1119","modality":"Small molecule (oral soft capsule), deuterated androgen receptor antagonist","mechanism":"A deuterated form of enzalutamide, a second-generation androgen receptor antagonist; in preclinical models it had a lower metabolic rate, higher plasma exposure and lower brain exposure than enzalutamide at equivalent doses.","approvals":[{"region":"China","year":2025,"indication":"Metastatic castration-resistant prostate cancer","note":"NMPA approval on 29 May 2025, per Hinova's pipeline page"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/deutenzalutamide/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"}],"target":[{"id":"androgen-receptor","kind":"target","name":"Androgen receptor","route":"/targets/androgen-receptor/"}],"company":[{"id":"hinova-pharmaceuticals","kind":"company","name":"Hinova Pharmaceuticals","route":"/companies/hinova-pharmaceuticals/"}],"trial":[{"id":"nct03778047","kind":"trial","name":"A Study Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch","route":"/trials/nct03778047/"},{"id":"nct03776968","kind":"trial","name":"A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics","route":"/trials/nct03776968/"},{"id":"nct03774056","kind":"trial","name":"A Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients.","route":"/trials/nct03774056/"},{"id":"nct03851640","kind":"trial","name":"A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).","route":"/trials/nct03851640/"},{"id":"nct03850795","kind":"trial","name":"HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","route":"/trials/nct03850795/"}]}}