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Oteracil | CAS No: 937-13-3 | GMP-certified suppliers
A medication that supports antineoplastic therapy by reducing gastrointestinal toxicity in adults treated for advanced gastric cancer in combination with chemotherapy agents.
Therapeutic categories
Primary indications
- Oteracil is used as an adjunct to antineoplastic therapy
- When used within the product Teysuno, oteracil is indicated for the treatment of adults with advanced gastric (stomach) cancer when given in combination with cisplatin
Product Snapshot
- Oteracil is available in oral tablet, soluble, and capsule formulations as a small molecule
- It is primarily used as an adjunct in antineoplastic therapy for advanced gastric cancer, specifically in combination with cisplatin
- Oteracil-containing products, such as Teysuno, are approved for use in the European Union
Clinical Overview
5-FU acts by mimicking natural pyrimidine nucleotides, essential for RNA and DNA synthesis. This incorporation disrupts nucleic acid replication, selectively targeting rapidly dividing cancer cells. Oteracil’s role within this combination is to decrease the activation and cytotoxic impact of 5-FU in normal gastrointestinal mucosa. It achieves this by inhibiting orotate phosphoribosyltransferase (OPRT), an enzyme necessary for converting pro-drugs into active 5-FU metabolites. This inhibition limits local 5-FU activity, thereby reducing chemotherapy-induced gastrointestinal side effects without compromising systemic antitumor efficacy.
Oteracil belongs to the chemical class of triazinones, which are characterized by a triazine ring containing a keto group. Its indications when used in Teysuno include treatment of adults with advanced gastric cancer, typically administered in combination with cisplatin.
Pharmacokinetic details specific to oteracil alone are not extensively documented, as it is primarily utilized to modulate 5-FU activity. Safety considerations largely revolve around its role in minimizing gastrointestinal toxicity during combination chemotherapy, although general toxicology data must be assessed within the context of combination use.
From an API sourcing perspective, quality control should focus on stringent adherence to purity specifications and stability profiles, given oteracil’s functional role in modulating enzymatic activity. Supply chain traceability and consistent compliance with pharmacopeial standards are essential to ensure reliable integration in global antineoplastic regimens.
Identification & chemistry
| Generic name | Oteracil |
|---|---|
| Molecule type | Small molecule |
| CAS | 937-13-3 |
| UNII | 5VT6420TIG |
| DrugBank ID | DB03209 |
Pharmacology
| Summary | Oteracil acts as an inhibitor of orotate phosphoribosyltransferase (OPRT), reducing the conversion and activity of 5-fluorouracil (5-FU) in gastrointestinal tissues. This selective inhibition aims to mitigate gastrointestinal toxicity associated with 5-FU-based chemotherapy. Oteracil is used adjunctively in antineoplastic regimens targeting advanced gastric cancer. |
|---|---|
| Mechanism of action | Oteracil's main role within Teysuno is to reduce the activity of 5-FU within normal gastrointestinal mucosa, and therefore reduce's gastrointestinal toxicity . It functions by blocking the enzyme orotate phosphoribosyltransferase (OPRT), which is involved in the production of 5-FU. |
ADME / PK
| Absorption | After administration of a single dose of 50 mg Teysuno (expressed as tegafur content), median Tmax for Teysuno components tegafur, gimeracil, and oteracil was 0.5, 1.0, and 2.0 hours, respectively . |
|---|---|
| Half-life | Following a single dose of Teysuno, T1/2 values ranged from 6.7 to 11.3 hours for tegafur, from 3.1 to 4.1 hours for gimeracil, and from 1.8 to 9.5 hours for oteracil . |
| Protein binding | Oteracil, gimeracil, 5-FU, and tegafur are 8.4%, 32.2%, 18.4%, and 52.3% protein bound, respectively . |
| Metabolism | Based on the results of in vitro studies, a part of oteracil is non-enzymatically degraded to 5-azauracil (5-AZU) by gastric fluid, and is then converted to cyanuric acid (CA) in the digestive tract. Only a small amount of oteracil is metabolised in the liver because of its low permeability . |
| Route of elimination | Following a single dose of Teysuno, approximately 3.8% to 4.2% of administered tegafur, 65% to 72% of administered gimeracil, and 3.5% to 3.9% of administered oteracil were excreted unchanged in the urine . |
| Volume of distribution | Although no intravenous data are available for Teysuno in humans, the volume of distribution could be roughly estimated from the apparent volume of distribution and urinary excretion data as 16 l/m2, 17 l/m2, and 23 l/m2 for tegafur, gimeracil and oteracil, respectively . |
Formulation & handling
- Oteracil is formulated for oral administration in soluble tablet, capsule, and tablet forms.
- It is a small molecule with moderate water solubility and low lipophilicity (LogP -1.2).
- Oteracil administration requires separation from meals by at least one hour before and after dosing to avoid food interactions.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently marketed in the EU, with key patents having expired or approaching expiration, indicating a mature market with established generic competition. Ongoing regulatory approvals support continued availability across member states. |
|---|
| Markets | EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Oteracil is characterized by the presence of originator companies offering branded products primarily in the EU market. The consistent branding under the name Teysuno suggests a focused portfolio within this region. Without data on patent status, it is unclear whether generic competition is imminent or currently established. |
|---|
Oteracil is a type of Other antibacterials
The category of pther antibacterials in the pharmaceutical API (Active Pharmaceutical Ingredient) industry encompasses a diverse range of antibacterial substances that are not classified under specific subcategories. These APIs exhibit potent antibacterial activity against various bacteria and play a crucial role in combating bacterial infections.
The Other antibacterials category includes several subclasses of pharmaceutical APIs, such as nitroimidazoles, fusidanes, polymyxins, and glycopeptides. Each subclass comprises specific chemical compounds that target different types of bacteria through distinct mechanisms of action.
Nitroimidazoles are effective against anaerobic bacteria and protozoa by interfering with their DNA replication. They are commonly used in the treatment of infections in the gastrointestinal tract, pelvic area, and respiratory system. Fusidanes, on the other hand, inhibit bacterial protein synthesis and are particularly active against Gram-positive bacteria. They find application in treating skin and soft tissue infections caused by Staphylococcus aureus.
Polymyxins are cyclic peptides that disrupt the integrity of bacterial cell membranes, rendering them inactive. These APIs are potent against Gram-negative bacteria and are often reserved for multidrug-resistant strains.
Glycopeptides, such as vancomycin, are essential for combating Gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA). They inhibit bacterial cell wall synthesis, leading to bacterial death.
The Other antibacterials category plays a critical role in providing effective treatment options for bacterial infections, particularly when other classes of antibacterials have shown limited efficacy. Pharmaceutical companies continually explore and develop new compounds within this category to address emerging antibiotic resistance and enhance patient care.
Oteracil API manufacturers & distributors
Compare qualified Oteracil API suppliers worldwide. We currently have 4 companies offering Oteracil API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, JDMF | 36 products |
| Shiratori Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 9 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Sumitomo Chemical | Producer | Japan | Japan | CoA, JDMF | 28 products |
When sending a request, specify which Oteracil API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Oteracil API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
