Darovasertib (LXS196) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

Darovasertib (LXS196) has been evaluated across multiple clinical trials investigating its therapeutic potential in primary and metastatic uveal melanoma, cutaneous melanoma, colorectal cancer, and solid tumors harboring GNAQ/11 mutations or PRKC fusions. These Phase 1, Phase 2, and Phase 3 studies—sponsored by organizations such as IDEAYA Biosciences, Novartis Pharmaceuticals, and St Vincent's Hospital, Sydney—encompass completed, terminated, and actively recruiting trials. Overall, the clinical landscape spans neoadjuvant interventions in localized disease to combination strategies for advanced metastatic ocular melanoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07804186	RECRUITING	Uveal Melanoma	IDEAYA Biosciences	2026-09	PHASE3
NCT07015190	RECRUITING	Uveal Melanoma	IDEAYA Biosciences	2026-01-25	PHASE3
NCT05907954	ACTIVE_NOT_RECRUITING	Uveal Melanoma	IDEAYA Biosciences	2023-07-03	PHASE2
NCT05987332	ACTIVE_NOT_RECRUITING	Metastatic Uveal Melanoma	IDEAYA Biosciences	2023-10-31	PHASE2; PHASE3
NCT05187884	COMPLETED	Ocular Melanoma	St Vincent's Hospital, Sydney	2022-05-03	PHASE2
NCT05907954	Recruiting	Uveal Melanoma	IDEAYA Biosciences	2023-07-03	Phase 2
NCT02601378	TERMINATED	Uveal Melanoma	Novartis Pharmaceuticals	2016-02-01	PHASE1
NCT03947385	Recruiting	Metastatic Uveal Melanoma\|Cutaneous Melanoma\|Colorectal Cancer\|Other Solid Tumors	IDEAYA Biosciences	2019-06-28	Phase 1\|Phase 2
NCT02601378	Terminated	Uveal Melanoma	Novartis Pharmaceuticals\|Novartis	2016-02-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Darovasertib (LXS196) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Darovasertib selectively binds to and inhibits protein kinase C (PKC), thereby suppressing downstream oncogenic signaling pathways that regulate cellular proliferation and survival. By blocking PKC activity driven by hyperactive upstream GNAQ/11 signaling, this compound disrupts tumor growth and viability, providing the mechanistic rationale for its clinical evaluation in primary and metastatic uveal melanoma.

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>).