Clinical Trials

Multiple clinical trials evaluate pyrimidine-related metabolic and photoprotective pathways across Phase 1, Phase 2, and non-applicable phase classifications for indications including melanoma, sun-damaged skin, dermal photosensitivity, and metastatic breast cancer. Conducted by academic institutions, healthcare networks, and industry sponsors, these studies differ in recruitment status. While a clinical trial investigating metabolic alterations in melanoma is actively recruiting, several clinical trials focusing on photosensitivity, photoprotection, and metastatic breast cancer are completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05307289 Recruiting
Melanoma (Skin)
Centre Hospitalier Universitaire de Nice
 2022-05-25 Not Applicable
NCT05926791 Completed
Sun Damaged Skin
Pierre Fabre Dermo Cosmetique
 2021-06-28 --
NCT04654312 Completed
Photosensitivity
Universität des Saarlandes
 2021-01-18 Phase 1
NCT00216021 Completed
Metastatic Breast Cancer
Hoosier Cancer Research Network|Sanofi|Hoffmann-La Roche|Walther Cancer Institute
 2004-03 Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Pyrimidine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a fundamental aromatic nitrogenous base and metabolic precursor, pyrimidine integrates into essential nucleotide biosynthetic pathways required for nucleic acid synthesis and cellular proliferation. Disruption or metabolic regulation of pyrimidine synthesis leads to impaired genomic stability and restricted cellular division, providing therapeutic relevance for limiting tumor progression in studied clinical conditions such as metastatic breast cancer and 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>).

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Note: Technical data last updated: Sep 1, 2026.