Find Crofelemer manufacturers, exporters & distributors on PharmaCompass

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ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 148465-45-6, Cid 17397714, Zinc9497828, Akos016487279, Z164754034, 923916-82-9
Molecular Formula
C18H16N2O3
Molecular Weight
308.3  g/mol
InChI Key
JDNAIBCYTQGWFC-UHFFFAOYSA-N

Crofelemer
1 2D Structure

Crofelemer

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[(2-methoxyphenyl)methyl]-5-phenyl-1,2-oxazole-3-carboxamide
2.1.2 InChI
InChI=1S/C18H16N2O3/c1-22-16-10-6-5-9-14(16)12-19-18(21)15-11-17(23-20-15)13-7-3-2-4-8-13/h2-11H,12H2,1H3,(H,19,21)
2.1.3 InChI Key
JDNAIBCYTQGWFC-UHFFFAOYSA-N
2.1.4 Canonical SMILES
COC1=CC=CC=C1CNC(=O)C2=NOC(=C2)C3=CC=CC=C3
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 148465-45-6

2. Cid 17397714

3. Zinc9497828

4. Akos016487279

5. Z164754034

6. 923916-82-9

2.3 Create Date
2007-11-13
3 Chemical and Physical Properties
Molecular Weight 308.3 g/mol
Molecular Formula C18H16N2O3
XLogP33.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass308.11609238 g/mol
Monoisotopic Mass308.11609238 g/mol
Topological Polar Surface Area64.4 Ų
Heavy Atom Count23
Formal Charge0
Complexity385
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameMYTESI
Active IngredientCROFELEMER
CompanyNAPO PHARMS INC (Application Number: N202292. Patents: 7323195, 7341744, 8574634, 8962680, 9585868)

NDC API

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SupplySide West 2024
Not Confirmed
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CROFELEMER

NDC Package Code : 66039-854

Start Marketing Date : 2013-06-01

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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02

Indena SpA

Italy
SupplySide West 2024
Not Confirmed
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Indena SpA

Italy
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SupplySide West 2024
Not Confirmed

CROFELEMER

NDC Package Code : 17359-8750

Start Marketing Date : 2023-12-18

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1623004200,"product":"CROFELEMER - BULK DRUG","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR IAL ESTATE, MOHOL BAZARPETH","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"MEMPHIS TN","customer":"SHARP","customerCountry":"UNITED STATES","quantity":"88.13","actualQuantity":"88.128","unit":"KGS","unitRateFc":"7138.8","totalValueFC":"616330.8","currency":"USD","unitRateINR":514347.74838870729,"date":"07-Jun-2021","totalValueINR":"45328438.37","totalValueInUsd":"616330.8","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"2263301","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR IAL ESTATE, MOHOL BAZARPETH, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642444200,"product":"CROFELEMER - BULK DRUG","address":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth","city":"Solapur","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"MEMPHIS, TN","customer":"SHARP","customerCountry":"UNITED STATES","quantity":"83.11","actualQuantity":"83.108","unit":"KGS","unitRateFc":"7926","totalValueFC":"651251.9","currency":"USD","unitRateINR":583746.45040188672,"date":"18-Jan-2022","totalValueINR":"48514000","totalValueInUsd":"651251.9","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"7546077","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth, Solapur","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654713000,"product":"CROFELEMER","address":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth","city":"Solapur","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"MEMPHIS, TN","customer":"THERMO FISHER SCIENTIFIC","customerCountry":"UNITED STATES","quantity":"80.87","actualQuantity":"80.874","unit":"KGS","unitRateFc":"7926","totalValueFC":"631017.3","currency":"USD","unitRateINR":608712.31792665133,"date":"09-Jun-2022","totalValueINR":"49229000","totalValueInUsd":"631017.3","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"2001756","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth, Solapur","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657132200,"product":"CROFELEMER","address":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth","city":"Solapur","supplier":"GLENMARK PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"MEMPHIS, TN","customer":"TO THE ORDER","customerCountry":"UNITED STATES","quantity":"68.44","actualQuantity":"68.436","unit":"KGS","unitRateFc":"7926","totalValueFC":"526959.6","currency":"USD","unitRateINR":612280.08650417905,"date":"07-Jul-2022","totalValueINR":"41902000","totalValueInUsd":"526959.6","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"2666016","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"Plot 170-172, Chandramouli Industrial Estate, Mohol Bazarpeth, Solapur","customerAddress":""}]
07-Jun-2021
07-Jul-2022
KGS
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Average Price (USD/KGS)

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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

Mytesi (crofelemer) is a CFTR/CaCC inhibitor small molecule drug administered orally as a delayed release tablet, for prophylaxis of diarrhea in cancer patients.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 08, 2024

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01

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Details : Mytesi (crofelemer) is a CFTR/CaCC inhibitor small molecule drug administered orally as a delayed release tablet, for prophylaxis of diarrhea in cancer patients.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 08, 2024

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Details:

Mytesi (crofelemer) is a plant-based drug extracted & purified from the red bark sap. It is being developed for relief and treatment of prophylaxis of diarrhea in cancer patients.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 01, 2024

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02

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Mytesi (crofelemer) is a plant-based drug extracted & purified from the red bark sap. It is being developed for relief and treatment of prophylaxis of diarrhea in cancer patients.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 01, 2024

blank

Details:

Mytesi (crofelemer) is a CFTR/CaCC inhibitor small molecule drug administered orally as a delayed release tablet, for prophylaxis of diarrhea in cancer patients.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 12, 2024

blank

03

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Mytesi (crofelemer) is a CFTR/CaCC inhibitor small molecule drug administered orally as a delayed release tablet, for prophylaxis of diarrhea in cancer patients.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 12, 2024

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Details:

Crofelemer is a novel, oral plant-based medicine purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 28, 2024

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04

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : Crofelemer is a novel, oral plant-based medicine purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 28, 2024

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Details:

The company submitted a CTA to the Italian and German health authorities to initiate a phase 2 trial of Mytesi (crofelemer) for the treatment of short bowel syndrome with intestinal failure in adults.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Jaguar Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 09, 2024

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05

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Details : The company submitted a CTA to the Italian and German health authorities to initiate a phase 2 trial of Mytesi (crofelemer) for the treatment of short bowel syndrome with intestinal failure in adults.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 09, 2024

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Details:

GEN will manufacture Mytesi (crofelemer) and market it for HIV-related diarrhea in Turkey and neighboring countries after receiving regulatory approval.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: GEN

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 20, 2024

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06

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Details : GEN will manufacture Mytesi (crofelemer) and market it for HIV-related diarrhea in Turkey and neighboring countries after receiving regulatory approval.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 20, 2024

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Details:

Crofelemer is a plant-based drug extracted from red bark sap, being developed for treating moderate-to-severe diarrhea from various infections, including Vibrio cholerae.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 12, 2024

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07

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Details : Crofelemer is a plant-based drug extracted from red bark sap, being developed for treating moderate-to-severe diarrhea from various infections, including Vibrio cholerae.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 12, 2024

blank

Details:

Mytesi (crofelemer) is a CFTR/CaCC inhibitor small molecule drug administered orally as a delayed release tablet, for prophylaxis of diarrhea in cancer patients.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 11, 2023

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08

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Details : Mytesi (crofelemer) is a CFTR/CaCC inhibitor small molecule drug administered orally as a delayed release tablet, for prophylaxis of diarrhea in cancer patients.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 11, 2023

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Details:

Under the agreement, Napo grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for a powder formulation of Mytesi (crofelemer), the only oral FDA-approved prescription drug under botanical guidance, for oral solution.


Lead Product(s): Crofelemer

Therapeutic Area: Gastroenterology Brand Name: Mytesi

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Quadri Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement November 02, 2023

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09

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Details : Under the agreement, Napo grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for a powder formulation of Mytesi (crofelemer), the only oral FDA-approved prescription drug under botanical guidance, for oral solution.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Undisclosed

November 02, 2023

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Details:

Mytesi (crofelemer) powder for oral solution inhibits both cAMP-stimulated CFTR chloride ion channel and the CaCC at the luminal membrane of enterocytes, which being investigated for the treatment of microvillus inclusion disease.


Lead Product(s): Crofelemer

Therapeutic Area: Genetic Disease Brand Name: Mytesi

Study Phase: IND EnablingProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 09, 2023

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10

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Napo EU

Italy
arrow
SupplySide West 2024
Not Confirmed

Details : Mytesi (crofelemer) powder for oral solution inhibits both cAMP-stimulated CFTR chloride ion channel and the CaCC at the luminal membrane of enterocytes, which being investigated for the treatment of microvillus inclusion disease.

Brand Name : Mytesi

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 09, 2023

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