> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/oteracil-6bad6a40-4113-4f92-a2ce-1fd23fc478de
> Record changed: 2026-10-13

# Oteracil

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

**Drug name**

Oteracil

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

**Molecular weight**

157.08

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

**Structure (SMILES)**

O=C(O)c1nc(=O)\[nH\]c(=O)\[nH\]1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

### Other names (21)

- 5 azaorotic acid
- 5-azaorotic acid
- allantoxanic acid
- Allantoxanic acid
- gimeracil and oteracil potassium capsule
- oteracil
- Oteracil
- OTERACIL \[EMA EPAR\]
- oteracil \[INN\]
- Oteracil \[WHO-DD\]
- oteracil ema epar
- oteracil inn
- oteracil who dd
- oteracilo
- Oteracilo
- oxonic acid
- Oxonic acid
- OXONIC ACID \[MI\]
- oxonic acid mi
- s triazine 2 4 dione 6 carboxylic acid
- S-TRIAZINE-2,4-DIONE-6-CARBOXYLIC ACID

## Identifiers

**CAS registry numbers**

- 937-13-3

**ChEMBL ID**

CHEMBL181932

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

**InChIKey**

RYYCJUAHISIHTL-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL181932)

**PubChem compound IDs**

- 4604

**FDA ingredient codes (UNII)**

- 5VT6420TIG

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Drug name stem**

\-racil

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
UMPS

**Protein identifier**  
P11172

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (35)

- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000178

**Subject identifier**  
D013274
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000181

**Subject identifier**  
D002294
- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Adenocarcinoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000228

**Subject identifier**  
D000230
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000365

**Subject identifier**  
D015179
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000503

**Subject identifier**  
D013274
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Small Cell Lung Carcinoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000702

**Subject identifier**  
D055752
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107
- **Condition**  
Pancreatic Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0002618

**Subject identifier**  
D010190
- **Condition**  
Esophageal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0002916

**Subject identifier**  
D004938
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Kidney Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003086

**Subject identifier**  
D007674
- **Condition**  
Pancreatic Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003860

**Subject identifier**  
D010190
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003869

**Subject identifier**  
D001943
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003897

**Subject identifier**  
D013274
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0004142

**Subject identifier**  
D015179
- **Condition**  
Cholangiocarcinoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0005221

**Subject identifier**  
D018281
- **Condition**  
Esophageal Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0005922

**Subject identifier**  
D004938
- **Condition**  
Head and Neck Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0006859

**Subject identifier**  
D006258
- **Condition**  
Pancreatic Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1000359

**Subject identifier**  
D010190
- **Condition**  
Rectal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000657

**Subject identifier**  
D012004
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0001056

**Subject identifier**  
D013274
- **Condition**  
Carcinoma, Neuroendocrine

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0002120

**Subject identifier**  
D018278
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0002974

**Subject identifier**  
D002583

And 10 more, listed on the interactive page.

### Open Targets indications (46)

- **Condition identifier**  
EFO\_0000181

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000182

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000365

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000503

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000616

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000702

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0002618

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003086

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003860

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003897
- **Condition identifier**  
EFO\_0004142

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0005221

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0005922

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0006859

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1000359

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0001056

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002120

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002974
- **Condition identifier**  
MONDO\_0003060
- **Condition identifier**  
MONDO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0003219

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0003219

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005008

**Highest recorded phase**  
3

And 21 more, listed on the interactive page.

### Reported adverse events (8)

- **Event**  
collateral circulation

**Reports**  
1

**Reporting signal score**

7.58695
- **Event**  
decreased appetite

**Reports**  
5

**Reporting signal score**

11.2788
- **Event**  
hepatic function abnormal

**Reports**  
3

**Reporting signal score**

8.87124
- **Event**  
hepatitis acute

**Reports**  
2

**Reporting signal score**

8.19425
- **Event**  
hepatitis b

**Reports**  
2

**Reporting signal score**

8.55681
- **Event**  
myositis

**Reports**  
2

**Reporting signal score**

7.67268
- **Event**  
portosplenomesenteric venous thrombosis

**Reports**  
1

**Reporting signal score**

8.28
- **Event**  
pyogenic granuloma

**Reports**  
2

**Reporting signal score**

13.2661

### Trial references (223)

- NCT00072787  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00072787)
- NCT00088816  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00088816)
- NCT00134095  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00134095)
- NCT00142350  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00142350)
- NCT00150670  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00150670)
- NCT00152217  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00152217)
- NCT00182611  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00182611)
- NCT00195572  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00195572)
- NCT00202969  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00202969)
- NCT00209638  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00209638)
- NCT00209664  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00209664)
- NCT00209729  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00209729)
- NCT00216034  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00216034)
- NCT00278863  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00278863)
- NCT00287768  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00287768)
- NCT00400179  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00400179)
- NCT00503321  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00503321)
- NCT00687843  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00687843)
- NCT00816543  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00816543)
- NCT00915382  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00915382)
- NCT00960349  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00960349)
- NCT00985556  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00985556)
- NCT01283204  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01283204)
- NCT01285557  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01285557)
- NCT01286766  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01286766)

And 198 more, listed on the interactive page.

## Chemical properties

**Hydrogen bond acceptors**

4

**Hydrogen bond donors**

3

**Polar surface area**

115.91

**Calculated partition coefficient (ALogP)**

\-1.84

**Calculated partition coefficient (XLogP)**

\-1

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

1

**Heavy atoms**

11

**Molecular formula**

C4H3N3O4

**Monoisotopic mass**

157.01235559

**Natural product**

Yes

## Evidence counts

**Recorded assays**

7

**Active assays**

0

## Related records

### Trials (18)

- [A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study](https://trialight.com/data/trial/a-lm-302-combination-with-other-anti-tumor-therapies-phase-f867e7b8-f10d-4281-8491-ff6441459c77.md)
- A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer
- A Phase lb/lI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
- A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
- CCRT Followed by Tegafur, Gimeracil and Oteracil Potassium in Cervical Cancer
- Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
- DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment
- Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
- Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
- Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients
- Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial
- Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
- Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
- Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach
- Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Advanced Gastric Carcinoma
- Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
- SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients
- Tripletrumab Combined With Oxaliplatin and Teggio (SOX) in First-line Treatment of Gastric and Gastroesophageal Junction Adenocarcinoma

### In development for (34)

- [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) Phase 3
- [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) Phase 3
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2
- Carcinoma of esophagus Phase 3
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Phase 1
- [Cholangiocarcinoma](https://trialight.com/data/condition/cholangiocarcinoma-3777afe4-5189-5eb1-82f8-0c3446cb902f.md) Phase 3
- [Colorectal adenocarcinoma](https://trialight.com/data/condition/colorectal-adenocarcinoma-49107d5a-ece1-5f2b-8783-f2077e298ffa.md) Phase 3
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 3
- [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) Phase 3
- [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) Phase 3
- [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) Phase 3
- Exocrine pancreatic carcinoma Phase 3
- [Gastric adenocarcinoma](https://trialight.com/data/condition/gastric-adenocarcinoma-6bb74a55-7ba6-53e3-a113-22296a84d6ae.md) Phase 3
- [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 3
- Gastric carcinoma Phase 3
- [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) Phase 3
- [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) Phase 3
- [Head and neck cancer](https://trialight.com/data/condition/head-and-neck-cancer-3a2645b9-a3db-5103-b6f8-5d2ec40c5339.md) Phase 3

---

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