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Teduglutide | CAS No: 197922-42-2 | GMP-certified suppliers
A medication that treats Short Bowel Syndrome in adults and children by enhancing intestinal absorption and reducing dependence on parenteral nutrition through mucosal growth stimulation.
Therapeutic categories
Primary indications
- Teduglutide is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support
Product Snapshot
- Teduglutide is a parenteral injectable peptide provided as lyophilized powder for solution
- Its primary therapeutic use is for the management of Short Bowel Syndrome (SBS) in patients dependent on parenteral support
- Teduglutide is approved for commercial use in the US, Canada, and EU markets
Clinical Overview
Clinically, teduglutide is indicated for the treatment of adults and pediatric patients aged one year and older with Short Bowel Syndrome (SBS) who rely on parenteral support. SBS is characterized by a significant reduction in functional intestinal length, leading to malabsorption and dependence on intravenous nutrition.
The pharmacological action of teduglutide centers on its role as a GLP-2 receptor agonist. It binds to receptors located on enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons within the submucosal and myenteric plexuses. This binding stimulates the release of growth mediators such as insulin-like growth factor-1 (IGF-1), nitric oxide, and keratinocyte growth factor (KGF), which promote mucosal growth including increased villus height and crypt depth. These morphological changes enhance intestinal absorptive capacity and reduce fecal output, thereby improving fluid and nutrient absorption without affecting cardiac repolarization intervals (QTc).
Pharmacokinetic data indicate that teduglutide is primarily eliminated through renal excretion. Safety considerations include monitoring for potential adverse effects related to intestinal growth stimulation, such as neoplastic growth, necessitating regular gastrointestinal evaluations during therapy.
Notable commercial formulations include brands utilized in specialized care centers managing SBS. API sourcing should emphasize compliance with cGMP standards, ensuring genetic stability of the recombinant production strain, consistent purity, and absence of endotoxins. Reliable supply chains with validated analytical characterization of the teduglutide peptide are critical for maintaining quality in downstream pharmaceutical formulation processes.
Identification & chemistry
| Generic name | Teduglutide |
|---|---|
| Molecule type | Biotech |
| CAS | 197922-42-2 |
| UNII | 7M19191IKG |
| DrugBank ID | DB08900 |
Pharmacology
| Summary | Teduglutide is a glucagon-like peptide-2 (GLP-2) receptor agonist that enhances intestinal absorption by promoting mucosal growth and increasing villus height and crypt depth. It acts on enteroendocrine cells, myofibroblasts, and enteric neurons to stimulate release of growth factors such as IGF-1, nitric oxide, and keratinocyte growth factor. These effects improve gastrointestinal fluid absorption and reduce fecal output in patients with Short Bowel Syndrome. |
|---|---|
| Mechanism of action | Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine in response to meals. GLP-2 increases intestinal and portal blood flow and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. This causes the release of insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). These growth factors may contribute to the increase in crypt cell growth and surface area of the gastric mucosa. Ultimately, absorption through the intestine is enhanced. |
| Pharmacodynamics | An enhancement of gastrointestinal fluid absorption (750-1000 mL/day) was observed following daily administrations of teduglutide. An increase in villus height and crypt depth of the intestinal mucosa was also noted. A decrease in fecal weight has also been observed. Teduglutide does not prolong the QTc interval. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucagon-like peptide 2 receptor | Humans | agonist |
ADME / PK
| Absorption | The pharmacokinetic profile of teduglutide (when administered subcutaneously) is described by a one-compartment model with first order absorption in the abdomen, arm, and thigh. With escalating doses, teduglutide demonstrates linear pharmacokinetics. Absolute bioavailability, SubQ = 88%; Tmax, SubQ = 3-5 hours; Cmax, 0.05 mg/kg SubQ, SBS patients = 36 ng/mL; AUC, 0.05 mg/kg SubQ, SBS patients = 0.15 µg•hr/mL; Teduglutide does not accumulate following multiple subcutaneous administrations. |
|---|---|
| Half-life | Terminal half-life, healthy subjects = 2 hours; Terminal half-life, SBS patients = 1.3 hours |
| Metabolism | Although a formal investigation has not been conducted, it is expected because teduglutide is a peptide-based drug, it will be degraded into smaller peptides and amino acids via catabolic pathways. The cytochrome P450 enzyme system is not involved in the metabolism of this drug. |
| Route of elimination | Urine |
| Volume of distribution | Vd, healthy subjects = 103 mL/kg |
| Clearance | Plasma clearance, healthy subjects = 123 mL/hr/kg; This value indicates that teduglutide is primarily cleared by the kidney. |
Formulation & handling
- Teduglutide is a peptide-based biotech API formulated primarily for subcutaneous injection in lyophilized powder form requiring reconstitution before use.
- Handling requires protection from physical and chemical degradation, with storage conditions likely involving refrigeration to maintain stability.
- The API is not intended for oral administration and presents typical biologic sensitivities such as potential denaturation upon exposure to inappropriate temperature or agitation.
Regulatory status
| Lifecycle | The API is marketed in the US, Canada, and EU, with key US patents expiring between 2020 and 2026, indicating varying levels of market exclusivity and progressing maturity across these regions. Post-patent expiration, generic competition may increase, impacting market dynamics. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Teduglutide is marketed under several branded products across the US, Canada, and EU, indicating multiple originator companies involved in its manufacture and supply. The presence of active patents extending through 2026 in the United States suggests ongoing patent protection, with generic competition likely limited until patent expirations. The global distribution of branded formulations demonstrates an established manufacturing and supply chain footprint in major pharmaceutical markets. |
|---|
Safety
| Toxicity | The most common adverse reactions (≥ 10%) across all studies with GATTEX are abdominal pain, injection site reactions, nausea, headaches, abdominal distension, upper respiratory tract infection. In addition, vomiting and fluid overload were reported in the SBS studies (1 and 3) at rates ≥ 10%. |
|---|
- Handle with appropriate protective equipment to minimize exposure due to potential gastrointestinal and systemic adverse effects
- Avoid release into the environment
- Fluid overload and injection site reactions have been associated with exposure
Teduglutide is a type of Gastrointestinal Agents
Gastrointestinal Agents belong to the pharmaceutical API category that focuses on treating disorders and ailments related to the digestive system. These agents play a crucial role in addressing various gastrointestinal conditions, such as acid reflux, ulcers, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).
One of the key types of gastrointestinal agents is proton pump inhibitors (PPIs), which work by reducing the production of stomach acid. PPIs help in treating conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Another essential class of agents is antacids, which neutralize excessive stomach acid, providing relief from heartburn and indigestion.
Gastrointestinal agents also include antispasmodics that alleviate abdominal cramps and spasms associated with conditions like IBS. These drugs work by relaxing the smooth muscles of the digestive tract. Additionally, there are drugs categorized as laxatives that aid in relieving constipation by promoting bowel movements.
Moreover, certain gastrointestinal agents act as antiemetics, effectively reducing nausea and vomiting. These drugs are particularly useful for patients undergoing chemotherapy or experiencing motion sickness.
Pharmaceutical companies develop and manufacture a wide range of gastrointestinal agents in various forms, including tablets, capsules, suspensions, and injections. These agents are typically formulated using active pharmaceutical ingredients (APIs) and other excipients to ensure their efficacy and safety.
In conclusion, gastrointestinal agents form a vital category of pharmaceutical APIs, providing relief from digestive disorders and improving overall gastrointestinal health. The availability of diverse agents catering to different conditions ensures that patients can receive targeted treatment for their specific gastrointestinal needs.
Teduglutide API manufacturers & distributors
Compare qualified Teduglutide API suppliers worldwide. We currently have 5 companies offering Teduglutide API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| AMBIOPHARM | Producer | United States | Unknown | CoA, USDMF | 10 products |
| Chengdu Shengnuo Biopharm... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 33 products |
| Guizhou Utide Biotechnolo... | Producer | China | China | CoA, MSDS | 7 products |
| Hangzhou Thinheal Pharma-... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 17 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, ISO9001 | 157 products |
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