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1. 6-amino-5-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-n-(4-(4-methylpiperazine-1-carbonyl)phenyl)pyridazine-3-carboxamide
2. Ensartinib
3. X-396
1. 1365267-27-1
2. X-376
3. X-396
4. 7dr7jmb8bh
5. Chembl2376648
6. 6-amino-5-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-n-[4-(4-methylpiperazine-1-carbonyl)phenyl]pyridazine-3-carboxamide
7. 3-pyridazinecarboxamide, 6-amino-5-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-n-(4-((4-methyl-1-piperazinyl)carbonyl)phenyl)-
8. Unii-7dr7jmb8bh
9. Gtpl8959
10. Schembl15131466
11. Bcp07190
12. Ex-a2227
13. Bdbm50432894
14. Nsc800968
15. S6505
16. Zinc96258164
17. Cs-6077
18. Db13104
19. Nsc-800968
20. Example 18 [wo2012048259]
21. Ac-35751
22. Hy-16590
23. X376
24. X 396
25. X-376; X-396
26. Q27077191
| Molecular Weight | 547.4 g/mol |
|---|---|
| Molecular Formula | C25H25Cl2FN6O3 |
| XLogP3 | 3.2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 6 |
| Exact Mass | 546.1349222 g/mol |
| Monoisotopic Mass | 546.1349222 g/mol |
| Topological Polar Surface Area | 114 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 784 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
Protein Kinase Inhibitors
Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)
NDC Package Code : 84637-4023
Start Marketing Date : 2023-12-13
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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Details:
As part of the agreement, Ensartinib will target ALK tyrosine kinase receptor in Non-Small-Cell Lung Carcinoma.
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Ensacove
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Eversana
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 27, 2026

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Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eversana
Deal Size : Undisclosed
Deal Type : Agreement
Xcovery Teams Up with EVERSANA to Market Lung Cancer Drug Ensacove in U.S.
Details : As part of the agreement, Ensartinib will target ALK tyrosine kinase receptor in Non-Small-Cell Lung Carcinoma.
Product Name : Ensacove
Product Type : Miscellaneous
Upfront Cash : Undisclosed
April 27, 2026

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Details:
MCLA-129 (Pamvatamig) is a antibody drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of neoplasms.
Lead Product(s): Pamvatamig,Ensartinib
Therapeutic Area: Oncology Brand Name: MCLA-129
Study Phase: Phase I/ Phase IIProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 04, 2026

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Lead Product(s) : Pamvatamig,Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.
Details : MCLA-129 (Pamvatamig) is a antibody drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of neoplasms.
Product Name : MCLA-129
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
March 04, 2026

Details:
Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Betta Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 17, 2025

Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD
Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 17, 2025

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Details:
Ensacove (ensartinib) is an ALK inhibitor, small molecule drug candidate, which is indicated for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Ensacove
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 18, 2024

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Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Ensartinib for ALK-Positive Locally Advanced or Metastatic NSCLC
Details : Ensacove (ensartinib) is an ALK inhibitor, small molecule drug candidate, which is indicated for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Product Name : Ensacove
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 18, 2024

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Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Ensartinib,Rifampicin,Itraconazole
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 09, 2024

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Lead Product(s) : Ensartinib,Rifampicin,Itraconazole
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 09, 2024

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Details:
X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2024

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Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts New Drug Application for Ensartinib
Details : X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 13, 2024

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Details:
Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2022

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Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2022

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NMPA’s nod in China marked first ensartinib approval based on results of eXalt3 study, an Xcovery sponsored randomized global phase III study, designed to evaluate the efficacy and safety of ensartinib in the first-line treatment of ALK-positive NSCLC.
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Betta Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2022

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Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Betta Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Ensartinib Secured Its First Approval for 1st Line Treatment in ALK+ NSCLC
Details : NMPA’s nod in China marked first ensartinib approval based on results of eXalt3 study, an Xcovery sponsored randomized global phase III study, designed to evaluate the efficacy and safety of ensartinib in the first-line treatment of ALK-positive NSCLC.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 22, 2022

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Details:
Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Fudan University
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 04, 2020

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Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Fudan University
Deal Size : Inapplicable
Deal Type : Inapplicable
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 04, 2020

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Details:
Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Lead Product(s): Ensartinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 31, 2019

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Lead Product(s) : Ensartinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Expanded Access to Ensartinib for Participants With ALK+ NSCLC
Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 31, 2019

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RLD : Yes
TE Code :
Brand Name : ENSACOVE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 25MG BASE
Approval Date : 2024-12-18
Application Number : 218171
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ENSACOVE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Approval Date : 2024-12-18
Application Number : 218171
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
14
PharmaCompass offers a list of Ensartinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ensartinib manufacturer or Ensartinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ensartinib manufacturer or Ensartinib supplier.
A Ensartinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ensartinib, including repackagers and relabelers. The FDA regulates Ensartinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ensartinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ensartinib supplier is an individual or a company that provides Ensartinib active pharmaceutical ingredient (API) or Ensartinib finished formulations upon request. The Ensartinib suppliers may include Ensartinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ensartinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ensartinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ensartinib API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ensartinib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ensartinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ensartinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ensartinib suppliers with NDC on PharmaCompass.
Ensartinib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ensartinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ensartinib GMP manufacturer or Ensartinib GMP API supplier for your needs.
A Ensartinib CoA (Certificate of Analysis) is a formal document that attests to Ensartinib's compliance with Ensartinib specifications and serves as a tool for batch-level quality control.
Ensartinib CoA mostly includes findings from lab analyses of a specific batch. For each Ensartinib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ensartinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ensartinib EP), Ensartinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ensartinib USP).