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Chemistry

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Also known as: Kpt-330, 1393477-72-9, Xpovio, Selinexor (kpt-330), Selinexor free base, (z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-1,2,4-triazol-1-yl)-n'-(pyrazin-2-yl)acrylohydrazide
Molecular Formula
C17H11F6N7O
Molecular Weight
443.3  g/mol
InChI Key
DEVSOMFAQLZNKR-RJRFIUFISA-N
FDA UNII
31TZ62FO8F

Selinexor
Selinexor is an orally available, small molecule inhibitor of CRM1 (chromosome region maintenance 1 protein, exportin 1 or XPO1), with potential antineoplastic activity. Selinexor modifies the essential CRM1-cargo binding residue cysteine-528, thereby irreversibly inactivates CRM1-mediated nuclear export of cargo proteins such as tumor suppressor proteins (TSPs), including p53, p21, BRCA1/2, pRB, FOXO, and other growth regulatory proteins. As a result, this agent, via the approach of selective inhibition of nuclear export (SINE), restores endogenous tumor suppressing processes to selectively eliminate tumor cells while sparing normal cells. CRM1, the major export factor for proteins from the nucleus to the cytoplasm, is overexpressed in a variety of cancer cell types.
1 2D Structure

Selinexor

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(Z)-3-[3-[3,5-bis(trifluoromethyl)phenyl]-1,2,4-triazol-1-yl]-N'-pyrazin-2-ylprop-2-enehydrazide
2.1.2 InChI
InChI=1S/C17H11F6N7O/c18-16(19,20)11-5-10(6-12(7-11)17(21,22)23)15-26-9-30(29-15)4-1-14(31)28-27-13-8-24-2-3-25-13/h1-9H,(H,25,27)(H,28,31)/b4-1-
2.1.3 InChI Key
DEVSOMFAQLZNKR-RJRFIUFISA-N
2.1.4 Canonical SMILES
C1=CN=C(C=N1)NNC(=O)C=CN2C=NC(=N2)C3=CC(=CC(=C3)C(F)(F)F)C(F)(F)F
2.1.5 Isomeric SMILES
C1=CN=C(C=N1)NNC(=O)/C=C\N2C=NC(=N2)C3=CC(=CC(=C3)C(F)(F)F)C(F)(F)F
2.2 Other Identifiers
2.2.1 UNII
31TZ62FO8F
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Kpt-330

2. Xpovio

2.3.2 Depositor-Supplied Synonyms

1. Kpt-330

2. 1393477-72-9

3. Xpovio

4. Selinexor (kpt-330)

5. Selinexor Free Base

6. (z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-1,2,4-triazol-1-yl)-n'-(pyrazin-2-yl)acrylohydrazide

7. Kpt 330

8. 31tz62fo8f

9. 2-propenoic Acid, 3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-1,2,4-triazol-1-yl)-, 2-(2-pyrazinyl)hydrazide, (2z)-

10. (z)-3-[3-[3,5-bis(trifluoromethyl)phenyl]-1,2,4-triazol-1-yl]-n'-pyrazin-2-ylprop-2-enehydrazide

11. 1621865-82-4

12. 2-propenoic Acid, 3-[3-[3,5-bis(trifluoromethyl)phenyl]-1h-1,2,4-triazol-1-yl]-, 2-(2-pyrazinyl)hydrazide, (2z)-

13. Selinexor [usan:inn]

14. Unii-31tz62fo8f

15. Nexpovio

16. Selinexor [inn]

17. Kpt330;selinexor

18. Xpovio (tn)

19. Kpt-330(selinexor)

20. Selinexor [mi]

21. Selinexor (usan/inn)

22. Selinexor [usan]

23. Selinexor [who-dd]

24. Selinexor [orange Book]

25. Chembl3545185

26. Schembl14678327

27. Gtpl10036

28. Ex-a870

29. Dtxsid801026013

30. Bdbm50527778

31. Mfcd27987944

32. Nsc780203

33. Nsc781780

34. Zinc96170454

35. Ccg-269161

36. Db11942

37. Nsc-780203

38. Nsc-781780

39. Ncgc00386310-01

40. Ncgc00386310-03

41. Ac-33645

42. Bs-15022

43. Compound 70 [wo2013019561a1]

44. N-hydroxy-n'-(2-phenylethyl)isophthalamide

45. S7252

46. Sw219336-1

47. D11222

48. A857179

49. J-690156

50. Q27256082

51. (2z)-2-(2-pyrazinyl)hydrazide-3-[3-[3,5-bis(trifluoromethyl)phenyl]-1h-1,2,4-triazol-1-yl]-2-propenoic Acid

52. Selinexor;(z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-1,2,4-triazol-1-yl)-n'-(pyrazin-2-yl)acrylohydrazide

2.4 Create Date
2013-06-10
3 Chemical and Physical Properties
Molecular Weight 443.3 g/mol
Molecular Formula C17H11F6N7O
XLogP33
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count12
Rotatable Bond Count5
Exact Mass443.09292697 g/mol
Monoisotopic Mass443.09292697 g/mol
Topological Polar Surface Area97.6 Ų
Heavy Atom Count31
Formal Charge0
Complexity621
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Selinexor is indicated for the treatment of relapsed or refractory multiple myeloma in combination with dexamethasone. Patients must have received at least 4 prior therapies and have disease which is refractory to least two proteasome inhibitors, at least two immunomodulatory agents, and an antiCD38 monoclonal antibody.


FDA Label


NEXPOVIO is indicated

- in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

- in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Selinexor causes cell cycle arrest and apoptosis in cancer cells.


5.2 ATC Code

L01XX66


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01X - Other antineoplastic agents

L01XX - Other antineoplastic agents

L01XX66 - Selinexor


5.3 Absorption, Distribution and Excretion

Absorption

A single 80 mg dose of selinexor produces a mean Cmax of 680 ng/mL and a mean AUC of 5386 ng*h/mL. This relationship is dose proportion over the range of 3-85 mg/m2 which encompasses the range of 0.06-1.8 times the approved dosage. The official FDA labeling reports the Tmax as 4 hours but phase 1 studies have found a range of 2-4 hours. Administering selinexor with food, either a high or low fat meal, results in an increase in the AUC of approximately 15-20% but this is not expected to be clinically significant.


Volume of Distribution

The mean apparent volume of distribution is 125 L. A phase 1 study reported mean apparent volumes of distribution ranging from 1.9-2.9 L/kg in their investigation of food and formulation effects.


Clearance

Selinexor has a mean apparent clearance of 17.9 L/h.


5.4 Metabolism/Metabolites

Selinexor is known to be metabolized through CYP3A4, UDPglucuronosyltransferases, and glutathione S-transferases although the metabolite profile has yet to be characterized in published literature. The primary metabolites found in urine and plasma are glucuronide conjugates.


5.5 Biological Half-Life

Selinexor has a mean half-life of elimination of 6-8 hours.


5.6 Mechanism of Action

Selinexor binds to and inhibits exportin-1 (XPO1). XPO1 is a nuclear exporter protein which contains a pocket to which nuclear proteins can bind. When complexed with these proteins and Ran, activated through guanosine triphosphate (GTP) binding, the XPO1-protein-Ran-GTP complex is able to exit the nucleus through a nuclear pore. Once outside, GTP is hydrolyzed and the complex dissociates. The inhibition of this process in cancer cells allows the targets of XPO1, many of which are tumor suppressors, to collect in the nucleus and result in increased transcription of tumor suppressor genes. Tumor suppressor proteins known to be affected by XPO1 inhibition include p53, p73, adenomatous polyposis coli, retinoblastoma, forkhead box protein O, breast cancer 1, nucleophosmin, and merlin. Regulators of cell cycle progression are also affected, namely p21, p27, galectin-3, and Tob. Inhibitor of NFB also collects in the nucleus as a result leading to reduced activity of NFB, a known contributor to cancer. XPO1 participates in the formation of a complex with eukaryotic initiation factor 4E and contributes to the transport of messenger RNA for several oncegenes including cell cycle promotors, cyclin D1, cyclin E, and CDK2/4/6, as well as antiapoptotic proteins, Mcl-1 and Bcl-xL. These wide ranging changes in protein expression and gene transcription culminate in cell cycle arrest and the promotion of apoptosis in cancer cells.


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ABOUT THIS PAGE

Selinexor Manufacturers

A Selinexor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selinexor, including repackagers and relabelers. The FDA regulates Selinexor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selinexor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Selinexor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Selinexor Suppliers

A Selinexor supplier is an individual or a company that provides Selinexor active pharmaceutical ingredient (API) or Selinexor finished formulations upon request. The Selinexor suppliers may include Selinexor API manufacturers, exporters, distributors and traders.

click here to find a list of Selinexor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Selinexor KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Selinexor Drug Master File in Korea (Selinexor KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Selinexor. The MFDS reviews the Selinexor KDMF as part of the drug registration process and uses the information provided in the Selinexor KDMF to evaluate the safety and efficacy of the drug.

After submitting a Selinexor KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Selinexor API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Selinexor suppliers with KDMF on PharmaCompass.

Selinexor NDC

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 Selinexor as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Selinexor API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Selinexor 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Selinexor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Selinexor NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Selinexor suppliers with NDC on PharmaCompass.

Selinexor GMP

Selinexor 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 Selinexor GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Selinexor GMP manufacturer or Selinexor GMP API supplier for your needs.

Selinexor CoA

A Selinexor CoA (Certificate of Analysis) is a formal document that attests to Selinexor's compliance with Selinexor specifications and serves as a tool for batch-level quality control.

Selinexor CoA mostly includes findings from lab analyses of a specific batch. For each Selinexor 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.

Selinexor may be tested according to a variety of international standards, such as European Pharmacopoeia (Selinexor EP), Selinexor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Selinexor USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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