Drugs / MK-6240
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Alzheimer disease | 2025-10-28 | “其在研产品 MK-6240（亦称为XTR006）的新药上市申请（NDA）已获得美国食品药品监督管理局（FDA）正式受理。” sinotau.com ↗ “FDA has accepted its New Drug Application (NDA) for MK-6240” lantheus.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03919669 | Apr 2019 → May 2022 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03860857 | May 2018 → Dec 2026 expected | Alzheimer disease | University of California, Irvine | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-08-14 | Lantheus Medical Imaging | Regulatory Lantheus Announces FDA Approval of TAUKLARIFY™ (Florquinitau F 18 Injection), an F18-Labeled Tau PET Imaging Agent for Alzheimer’s Disease lantheus.com ↗ |
| 2025-11-06 | Lantheus Medical Imaging | Regulatory Lantheus Reports Third Quarter 2025 Financial Results and Provides Business Update lantheus.com ↗
Announced PDUFA dates for its new formulation of piflufolastat F 18 PSMA PET imaging agent; for MK-6240 |
| 2025-11-05 | Sinotau Pharmaceutical Group | Regulatory DA受理先通医药合作伙伴Lantheus创新核药上市申请 sinotau.com ↗
先通医药合作伙伴Lantheus(NASDAQ: LNTH)近日宣布，其在研产品 MK-6240（亦称为XTR006）的新药上市申请（NDA）已获得美国食品药品监督管理局（FDA）正式受理。 |
| 2025-10-28 | Lantheus Medical Imaging | Regulatory Lantheus Announces FDA Acceptance of New Drug Application for MK-6240, a PET Imaging Agent Targeting Tau in Alzheimer’s Disease lantheus.com ↗
the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240 |
| 2025-04-30 | Lantheus Medical Imaging | Results Lantheus Announces Alzheimer’s Disease Radiodiagnostic MK-6240 Meets Co-Primary Endpoints in Two Pivotal Studies lantheus.com ↗
today announced that its clinical-stage F18-labeled tau Positron Emission Tomography (PET) radiodiagnostic, MK-6240 (F18-florquinitau), successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-14 | Lantheus Medical Imaging | Lantheus Announces FDA Approval of TAUKLARIFY™ (Florquinitau F 18 Injection), an F18-Labeled Tau PET Imaging Agent for Alzheimer’s Disease lantheus.com ↗ |
| 2025-11-06 | Lantheus Medical Imaging | Lantheus Reports Third Quarter 2025 Financial Results and Provides Business Update lantheus.com ↗ |
| 2025-11-05 | Sinotau Pharmaceutical Group | DA受理先通医药合作伙伴Lantheus创新核药上市申请 sinotau.com ↗ |
| 2025-10-28 | Lantheus Medical Imaging | Lantheus Announces FDA Acceptance of New Drug Application for MK-6240, a PET Imaging Agent Targeting Tau in Alzheimer’s Disease lantheus.com ↗ |
| 2025-04-30 | Lantheus Medical Imaging | Lantheus Announces Alzheimer’s Disease Radiodiagnostic MK-6240 Meets Co-Primary Endpoints in Two Pivotal Studies lantheus.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MK-6240 | “All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240” NCT03919669 ↗ |
| Modality | Diagnostic / imaging agent | “which is a radio tracer that gets injected prior to a positron emission tomography (PET) scan.” NCT03860857 ↗ |