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Nintedanib | CAS No: 656247-17-5 | GMP-certified suppliers
A medication that treats idiopathic pulmonary fibrosis and other progressive interstitial lung diseases and supports therapy for previously treated adenocarcinoma‑type non‑small cell lung cancer.
Therapeutic categories
Primary indications
- Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease
- It is also indicated for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype
- In the EU, under the brand name Vargatef, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy
Product Snapshot
- Oral small‑molecule tyrosine kinase inhibitor supplied as capsules
- Used for idiopathic pulmonary fibrosis, systemic‑sclerosis associated interstitial lung disease, other chronic fibrosing ILDs with a progressive phenotype, and in the EU for combination use in certain previously treated adenocarcinoma NSCLC settings
- Approved in the US, EU, and Canada
Clinical Overview
The pharmacological activity of nintedanib derives from competitive inhibition of receptor tyrosine kinases involved in fibrotic signaling and tumour angiogenesis. It targets PDGFR alpha and beta, FGFR 1–3, VEGFR 1–3, and FLT3, blocking ATP binding and reducing downstream proliferative and migratory signaling in lung fibroblasts. Additional inhibition of the non‑receptor tyrosine kinases Lck, Lyn, and Src further contributes to suppression of pathways implicated in fibrosis progression.
Pharmacodynamically, these actions slow structural lung decline in fibrotic disease and modulate endothelial and perivascular cell activity within tumour microenvironments. The compound is a substrate of CYP3A4, UGT1A1, OCT1, and P‑glycoprotein, and is also reported to inhibit OCT1 and P‑glycoprotein. These characteristics underscore the relevance of transporter and metabolic interactions, particularly in polypharmacy settings or when co‑administered with potent CYP3A4 modulators.
Nintedanib has a recognized risk of drug‑induced liver injury, especially during the first three months of treatment. Baseline and periodic liver function assessments are required. Use is not recommended in patients with moderate to severe hepatic impairment. Additional safety considerations include gastrointestinal adverse effects and potential bleeding risk, the latter relevant when combined with other agents affecting hemostasis.
For API procurement, suppliers should document impurity profiles, residual solvent controls, and stability data aligned with ICH expectations. Consistency in crystallinity, particle characteristics, and polymorph form is important to support reliable formulation performance and regulatory acceptance.
Identification & chemistry
| Generic name | Nintedanib |
|---|---|
| Molecule type | Small molecule |
| CAS | 656247-17-5 |
| UNII | G6HRD2P839 |
| DrugBank ID | DB09079 |
Pharmacology
| Summary | Nintedanib is a small‑molecule inhibitor of multiple receptor and non‑receptor tyrosine kinases that regulate pathways involved in fibrosis and angiogenesis. By blocking PDGFR, FGFR, VEGFR, FLT3, and selected Src‑family kinases, it suppresses fibroblast proliferation, migration, and pro‑angiogenic signalling. These combined effects underlie its use in fibrotic lung disease and certain oncology settings. |
|---|---|
| Mechanism of action | Nintedanib is a small molecule, competitive, triple angiokinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Many of these RTKs are implicated in lung fibrosis and tumour angiogenesis, so nintedanib is therefore used in the treatment of proliferative diseases such as idiopathic pulmonary fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease.The specific RTKs that nintedanib inhibits are platelet-derived growth factor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, and Fns-Like tyrosine kinase-3 (FLT3).Nintedanib binds to the ATP-binding pocket of these receptors and inhibits their activity, thereby blocking signalling cascades that result in the proliferation and migration of lung fibroblasts. Nintedanib also inhibits kinase signalling pathways in various cells within tumour tissues, including endothelial cells, pericytes, smooth muscle cells, and cells contributing to angiogenesis, culminating in an inhibition of cell proliferation and apoptosis of affected tumour cells. In addition to RTK inhibition, nintedanib also prevents the actions of the nRTKs Lck, Lyn, and Src.The contribution of the inhibition of Lck and Lyn towards the therapeutic efficacy of nintedanib is unclear, but inhibition of the Src pathway by nintedanib has been shown to reduce lung fibrosis. |
| Pharmacodynamics | Nintedanib is a small molecule kinase inhibitor that inhibits upstream kinase activity to ultimately inhibit lung fibroblast proliferation and migration, as well as signalling pathways that promote the proliferation and survival of endothelial and perivascular cells in tumour tissues. Nintedanib poses a risk of drug-induced liver injury, especially within the first three months of therapy.Liver function tests should be conducted at baseline prior to beginning therapy, at regular intervals for the first three months of therapy, and as indicated thereafter in patients exhibiting symptoms of hepatic injury such as jaundice or right upper quadrant pain. It is not recommended to be used in patients with pre-existing moderate to severe hepatic impairment (Child Pugh class B or C). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Vascular endothelial growth factor receptor 1 | Humans | inhibitor |
| Vascular endothelial growth factor receptor 2 | Humans | inhibitor |
| Vascular endothelial growth factor receptor 3 | Humans | inhibitor |
ADME / PK
| Absorption | The absolute bioavailability of nintedanib is low at approximately 4.7%, likely owing to substantial first-pass metabolism and the effects of p-glycoprotein (P-gp) transporters.T<sub>max</sub> following oral administration is reached after approximately 2 hours in fasted patients and approximately 4 hours in fed patients, regardless of the food consumed.Administration of nintedanib following a high-fat, high-calorie meal resulted in an increase in C<sub>max</sub> by approximately 15% and an increase in AUC by approximately 20%.Age, body weight, and smoking status have been found to alter exposure to nintedanib, but these effects are not significant enough to warrant dose alterations. |
|---|---|
| Half-life | The terminal elimination half-life of nintedanib is approximately 10-15 hours.In patients with idiopathic pulmonary fibrosis, the effective half-life of nintedanib has been estimated to be approximately 9.5 hours. |
| Protein binding | Plasma protein binding of nintedanib is high, with a bound fraction of 97.8%. Albumin is thought to be the major binding protein. |
| Metabolism | Nintedanib is predominantly metabolized via hydrolytic cleavage by esterases to its principle metabolite, BIBF 1202, which then undergoes glucuronidation via UGT enzymes in the intestines and liver (specifically UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10) to form BIBF 1202 glucuronide.The CYP450 enzyme system plays a minor role in nintedanib metabolism, with CYP3A4 believed to be the main contributor - the major CYP-dependent metabolite of nintedanib, a demethylated metabolite termed BIBF 1053, could not be detected in plasma during pharmacokinetic studies and was found only in small quantities in the feces (approximately 4% of total dose).CYP-dependent metabolism of nintedanib accounts for roughly 5% of total drug metabolism, as opposed to 25% for esterase cleavage.Other minor metabolites, M7 and M8, are found in very small quantities in the urine (0.03% and 0.01%, respectively), though their origin and relevance is currently unclear. |
| Route of elimination | Nintedanib is eliminated primarily via fecal and biliary excretion, with 93.4% of radio labelled nintedanib found in feces within 120 hours following administration.Renal clearance accounts for a small portion of nintedanib's elimination, approximately 0.65% of the total dose, and excretion of unchanged nintedanib 48 hours after oral and intravenous doses was 0.05% and 1.4%, respectively. |
| Volume of distribution | Nintedanib appears to follow biphasic disposition kinetics - the observed volume of distribution following intravenous administration is 1050 L, indicating extensive distribution into peripheral tissues. In rats, nintedanib was shown to rapidly and homogeneously distribute into peripheral tissues with the exception of the CNS, suggestive of an inability of nintedanib to cross the blood-brain barrier. |
| Clearance | Nintedanib is has a high total plasma clearance of approximately 1390 mL/min and a renal clearance of 20 mL/min. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, typically formulated in soft‑gel or liquid‑filled capsules to support dissolution and consistent exposure.
- Moderate lipophilicity (LogP ~2.8) and poor water solubility require solubilization approaches and protection from precipitation in gastric conditions.
- Absorption is food‑dependent, so formulations should be designed to maintain performance under fed conditions and minimize variability.
Regulatory status
| Lifecycle | The API is in a mature phase in Canada, the US, and the EU, with several core U.S. patents already expired in 2024 and additional protections ending between 2026 and 2029. Remaining later‑expiring patents suggest a gradual shift toward broader generic competition as these protections lapse. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Nintedanib is supplied by a single originator product alongside multiple generic-branded versions, indicating both innovator and non‑originator manufacturers in the market. Branded and generic presentations appear across the US, EU, and Canada, reflecting established global distribution. Several key US patents have recently expired, while others extend to 2026 and 2029, suggesting partial ongoing protection with existing or expanding generic competition in some markets. |
|---|
Safety
| Toxicity | Experience with nintedanib overdose is limited, but patients who inadvertently received higher-than-intended doses during initial trials experienced adverse effects consistent with the known safety profile of nintedanib, for example elevated liver enzymes and significant gastrointestinal effects. There are no specific guidelines for the treatment of nintedanib overdose - in this case, therapy should be interrupted and general supportive measures employed as indicated. |
|---|
- Overexposure has been associated with elevations in hepatic enzymes and pronounced gastrointestinal intolerance, reflecting the compound’s established safety profile
- No compound‑specific remediation protocols are defined
- Management in overdose settings relies on nonspecific supportive measures
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Nintedanib is a type of Protein kinase inhibitors
Protein kinase inhibitors are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in targeted cancer therapies. These inhibitors specifically target and block the activity of protein kinases, enzymes that regulate various cellular processes, including cell growth, division, and signal transduction.
Protein kinase inhibitors function by binding to the active site of protein kinases, preventing them from phosphorylating specific proteins and disrupting intracellular signaling pathways. This targeted approach inhibits the uncontrolled growth and proliferation of cancer cells, ultimately leading to their death.
The development of protein kinase inhibitors has revolutionized cancer treatment by providing more effective and less toxic alternatives to traditional chemotherapy. These drugs have demonstrated impressive results in the treatment of various cancers, including lung, breast, and leukemia.
The pharmaceutical industry invests heavily in research and development to discover novel protein kinase inhibitors with improved potency, selectivity, and pharmacokinetic properties. High-throughput screening, computational modeling, and structure-activity relationship studies are employed to identify potential lead compounds.
The success of protein kinase inhibitors in treating cancer has spurred significant interest in this subcategory of APIs. Ongoing research aims to expand their applications to other diseases, such as autoimmune disorders and neurological conditions.
In conclusion, protein kinase inhibitors are a valuable class of pharmaceutical APIs with immense potential for targeted cancer therapies. Continued advancements in this field hold promise for improved treatment outcomes and enhanced patient care.
Nintedanib (Protein kinase inhibitors), classified under Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
Nintedanib API manufacturers & distributors
Compare qualified Nintedanib API suppliers worldwide. We currently have 8 companies offering Nintedanib 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 |
|---|---|---|---|---|---|
| Cipla | Producer | India | India | CoA, USDMF | 164 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shilpa Medicare Ltd | Producer | India | India | CoA, FDA, GMP, ISO9001 | 54 products |
| Sun Pharma | Producer | India | India | CoA, USDMF | 219 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 144 products |
When sending a request, specify which Nintedanib 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 Nintedanib 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.
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