Uracil

Summary

Uracil (CHEMBL566) is a phase-3 clinical-stage small-molecule prodrug; indicated across 14 conditions including breast neoplasm and head and neck cancer.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Small molecule
• Indications: 14 conditions
• Clinical trials: 8
• Chemistry: 112.09 Da · C4H4N2O2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL566
Name	Uracil
Type	Small molecule
Max phase	3
FDA approved	no
PubChem CID	1174
ChEBI	CHEBI:17568
Molecular formula	C4H4N2O2
Molecular weight	112.09
InChIKey	ISAKRJDGNUQOIC-UHFFFAOYSA-N

SMILES: C1=CNC(=O)NC1=O

IUPAC name: 1H-pyrimidine-2,4-dione

ChEBI definition: A common and naturally occurring pyrimidine nucleobase in which the pyrimidine ring is substituted with two oxo groups at positions 2 and 4. Found in RNA, it base pairs with adenine and replaces thymine during DNA transcription.

Pharmacological roles (ChEBI): prodrug, allergen.

Other ChEBI roles (chemical / environmental): human metabolite, Daphnia magna metabolite, Saccharomyces cerevisiae metabolite, Escherichia coli metabolite, mouse metabolite.

Also known as: Fluorouracil specified compound c, Hybar x, Lamivudine impurity e, Lamivudine impurity e rs, NSC-3970, Pyrod, SQ-6201, SQ-7726, SQ-8493, Uracil, SID70371, URACIL

Patent coverage: 73,377 distinct patent families (235,501 SureChEMBL compound mentions), from 7 matched compound structure(s). One matched structure accounts for 232,529 (99%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Protein cereblon.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

14 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
breast neoplasm	3	MONDO:0021100	EFO:0003869
head and neck cancer	3	MONDO:0005627	EFO:0006859
rectal cancer	3	MONDO:0006519	EFO:1000657
gastric neoplasm	3	MONDO:0021085	MONDO:0001056
colorectal neoplasm	3	MONDO:0005335	MONDO:0005575
hepatocellular carcinoma	2	MONDO:0007256	EFO:0000182
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
oral cavity squamous cell carcinoma	2	MONDO:0004958	EFO:0000199
neoplasm	1	MONDO:0005070	EFO:0000616

5 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 8.

Phase distribution

Phase	Trials
Not specified	3
PHASE3	2
PHASE2	2
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00207831	PHASE3	TERMINATED	Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
NCT00378716	PHASE3	COMPLETED	Combination Chemotherapy in Treating Patients With Resected Colon Cancer
NCT00519688	PHASE2	COMPLETED	UFUR Plus Thalidomide for Advanced Hepatocellular Carcinoma
NCT04356170	PHASE2	COMPLETED	Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma
NCT01074710	PHASE1	COMPLETED	Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers
NCT06490003	Not specified	RECRUITING	Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma
NCT07501442	Not specified	NOT_YET_RECRUITING	Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
NCT04918264	Not specified	COMPLETED	Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 0 clinical and 6 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).