Tovorafenib (MLN2480) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Tovorafenib (DAY101/MLN2480) is evaluated across numerous clinical trials spanning Early Phase I through Phase III, targeting pediatric and adult low-grade glioma, advanced solid tumors with MAPK pathway alterations, hairy cell leukemia, and craniopharyngioma. Sponsored by pharmaceutical companies, academic medical centers, and government institutes, study statuses include recruiting, active not recruiting, terminated, completed, and approved for marketing. Phase III trials are actively evaluating the drug's therapeutic efficacy across these oncological conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07206849	NOT_YET_RECRUITING	High Grade Glioma (HGG) of the Brain With BRAF Aberration; High Grade Glioma (III or IV); Diffuse Intrinsic Pontine Glioma; High Grade Glioma; WHO Grade 3 Glioma; WHO Grade 4 Glioma; Metastatic Brain Tumor	Nationwide Children's Hospital	2026-11	PHASE2
NCT07441707	ACTIVE_NOT_RECRUITING	Low-grade Glioma	Ipsen	2026-03-10	PHASE1
NCT06965114	RECRUITING	Hairy Cell Leukemia; Recurrent Hairy Cell Leukemia; Refractory Hairy Cell Leukemia	National Cancer Institute (NCI)	2026-05-29	PHASE1; PHASE2
NCT05828069	RECRUITING	Recurrent Langerhans Cell Histiocytosis; Refractory Langerhans Cell Histiocytosis	National Cancer Institute (NCI)	2024-03-28	PHASE2
NCT05566795	ACTIVE_NOT_RECRUITING	Low-grade Glioma; Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma; Pediatric Low-grade Glioma	Day One Biopharmaceuticals, Inc.	2023-02-27	PHASE3
NCT04775485	RECRUITING	Low-grade Glioma; Advanced Solid Tumor	Day One Biopharmaceuticals, Inc.	2021-04-22	PHASE2
NCT06381570	RECRUITING	Low-grade Glioma	Daniel Morgenstern	2024-03-21	EARLY_PHASE1
NCT05465174	RECRUITING	Craniopharyngioma, Child; Craniopharyngioma; Recurrent Craniopharyngioma	Sabine Mueller, MD, PhD	2022-09-12	PHASE2
NCT03429803	COMPLETED	Low-grade Glioma	Karen D. Wright, MD	2018-02-27	PHASE1
NCT07121829	TERMINATED	Melanoma; Solid Tumor; Pilocytic Astrocytoma; Non Small Cell Lung Cancer; Colorectal Cancer; Pancreatic Cancer; MAP Kinase Family Gene Mutation; RAS Mutation; RAF Mutation; MEK Mutation	Day One Biopharmaceuticals, Inc.	2022-05-02	PHASE1
NCT04985604	TERMINATED	Melanoma; Solid Tumor; CRAF Gene Amplification; RAF1 Gene Amplification; BRAF Gene Fusion; BRAF Fusion; CRAF Gene Fusion; CRAF Fusion; RAF1 Gene Fusion; RAF1 Fusion; Thyroid Cancer, Papillary; Spitzoid Melanoma; Pilocytic Astrocytoma; Pilocytic Astrocytoma, Adult; Non Small Cell Lung Cancer; Non-Small Cell Adenocarcinoma; Colorectal Cancer; Pancreatic Acinar Carcinoma; Spitzoid Malignant Melanoma; Bladder Cancer; Bladder Urothelial Carcinoma; MAP Kinase Family Gene Mutation; RAF Mutation	Day One Biopharmaceuticals, Inc.	2021-07-15	PHASE2
NCT06381570	Recruiting	Low-grade Glioma	Daniel Morgenstern\|The Hospital for Sick Children	2024-03-21	Early Phase 1
NCT05566795	Recruiting	Low-grade Glioma	Day One Biopharmaceuticals Inc.\|SIOPe Brain Tumor Group LOGGIC Consortium	2023-02-27	Phase 3
NCT04985604	Recruiting	Melanoma\|Solid Tumor\|CRAF Gene Amplification\|RAF1 Gene Amplification\|BRAF Gene Fusion\|BRAF Fusion\|CRAF Gene Fusion\|CRAF Fusion\|RAF1 Gene Fusion\|RAF1 Fusion\|Thyroid Cancer Papillary\|Spitzoid Melanoma\|Pilocytic Astrocytoma\|Pilocytic Astrocytoma Adult\|Non Small Cell Lung Cancer\|Non-Small Cell Adenocarcinoma\|Colorectal Cancer\|Pancreatic Acinar Carcinoma\|Spitzoid Malignant Melanoma\|Bladder Cancer\|Bladder Urothelial Carcinoma\|MAP Kinase Family Gene Mutation\|RAS Mutation\|RAF Mutation\|MEK Mutation	Day One Biopharmaceuticals Inc.	2021-07-15	Phase 1\|Phase 2
NCT04775485	Recruiting	Low-grade Glioma\|Advanced Solid Tumor	Day One Biopharmaceuticals Inc.\|Pacific Pediatric Neuro-Oncology Consortium	2021-04-22	Phase 2
NCT02327169	COMPLETED	Advanced Nonhematologic Malignancies	Millennium Pharmaceuticals, Inc.	2015-01-14	PHASE1
NCT03429803	Active not recruiting	Low-grade Glioma	Karen D. Wright MD\|PLGA Fund at Pediatric Brain Tumor Foundation\|National Cancer Institute (NCI)\|Pacific Pediatric Neuro-Oncology Consortium\|Team Jack Foundation\|Day One Biopharmaceuticals Inc.\|Dana-Farber Cancer Institute	2018-02-27	Phase 1
NCT01425008	COMPLETED	Melanoma; Metastatic Melanoma; Solid Tumor; Neoplasm	Millennium Pharmaceuticals, Inc.	2011-09-15	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-31)

Check the Tovorafenib (MLN2480) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tovorafenib selectively binds to and inhibits RAF kinase isoforms, preventing downstream MEK and ERK phosphorylation within the MAPK signaling cascade to block pro-survival oncogenic signaling. This selective biochemical blockade arrests tumor cell cycle progression and induces apoptosis, demonstrating targeted therapeutic activity in pediatric low-grade gliomas and solid tumors harboring BRAF or CRAF gene alterations.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).