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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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API REF. PRICE (USD/KG)

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GLOBAL SALES INFORMATION

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Chemistry

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Also known as: Aficamten [inn], Aficamten [usan], 2364554-48-1, B1i77mh6k1, Chembl4847050, Ck-3773274
Molecular Formula
C18H19N5O2
Molecular Weight
337.4  g/mol
InChI Key
IOVAZWDIRCRMTM-OAHLLOKOSA-N
FDA UNII
B1I77MH6K1

Aficamten
1 2D Structure

Aficamten

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[(1R)-5-(5-ethyl-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1H-inden-1-yl]-1-methylpyrazole-4-carboxamide
2.1.2 InChI
InChI=1S/C18H19N5O2/c1-3-16-21-17(22-25-16)12-4-6-14-11(8-12)5-7-15(14)20-18(24)13-9-19-23(2)10-13/h4,6,8-10,15H,3,5,7H2,1-2H3,(H,20,24)/t15-/m1/s1
2.1.3 InChI Key
IOVAZWDIRCRMTM-OAHLLOKOSA-N
2.1.4 Canonical SMILES
CCC1=NC(=NO1)C2=CC3=C(C=C2)C(CC3)NC(=O)C4=CN(N=C4)C
2.1.5 Isomeric SMILES
CCC1=NC(=NO1)C2=CC3=C(C=C2)[C@@H](CC3)NC(=O)C4=CN(N=C4)C
2.2 Other Identifiers
2.2.1 UNII
B1I77MH6K1
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Aficamten [inn]

2. Aficamten [usan]

3. 2364554-48-1

4. B1i77mh6k1

5. Chembl4847050

6. Ck-3773274

7. 1h-pyrazole-4-carboxamide, N-((1r)-5-(5-ethyl-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1h-inden-1-yl)-1-methyl-

8. N-((1r)-5-(5-ethyl-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1h-inden-1-yl)- 1-methyl-1h-pyrazole-4-carboxamide

9. Unii-b1i77mh6k1

10. Schembl21179170

11. Gtpl11524

12. Ex-a5344

13. Bdbm50575173

14. Ck-274

15. Who 11544

16. Ck3773274

17. Hy-139465

18. Ck-3773274;ck-274

19. Cs-0202223

20. (r)-n-(5-(5-ethyl-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1h-inden-1-yl)-1-methyl-1h-pyrazole-4-carboxamide

21. N-[(1r)-5-(5-ethyl-1,2,4-oxadiazol-3-yl)-2,3-dihydro-1h-inden-1-yl]-1-methylpyrazole-4-carboxamide

2.4 Create Date
2019-11-02
3 Chemical and Physical Properties
Molecular Weight 337.4 g/mol
Molecular Formula C18H19N5O2
XLogP32.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count4
Exact Mass337.15387487 g/mol
Monoisotopic Mass337.15387487 g/mol
Topological Polar Surface Area85.8 Ų
Heavy Atom Count25
Formal Charge0
Complexity490
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Ningbo Inno Pharmchem

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
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Ningbo Inno Pharmchem

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BOC Sciences

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BOC Sciences

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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GLP Bio

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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GLP Bio

U.S.A

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EOS Med Chem

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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EOS Med Chem

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Biomol

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
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Biomol

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Zydus Lifesciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Zydus Lifesciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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NDC API

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AFICAMTEN

NDC Package Code : 59116-6280

Start Marketing Date : 2020-04-06

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

  • fda
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  • WHO-GMP

Virtual BoothMaithri Drugs: Dedicated to your API needs.

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Digital Content Digital Content

Aficamten

About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...

Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, antibiotics, ARVs, CNS, and cardiovascular segments. The company operates facilities approved by US FDA, EDQM, Health Canada, and WHO-GMP, supported by multiple global DMFs and Ecovadis recognition. Backed by strong R&D, global patents, and customer-focused practices, Maithri delivers high-quality APIs with regulatory excellence. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Aficamten

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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03

Biomol

Germany
BIO Partnering at JPM
Not Confirmed
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Biomol

Germany
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Aficamten

About the Company : Biomol GmbH, founded in 1968 in Heidelberg and later relocated to Hamburg, is a leading supplier of life science products in Germany. The company offers a wide range of research pr...

Biomol GmbH, founded in 1968 in Heidelberg and later relocated to Hamburg, is a leading supplier of life science products in Germany. The company offers a wide range of research products, including antibodies, biochemicals, and assay kits, supporting various scientific fields such as cell biology and biomedicine. Over the years, Biomol has expanded its portfolio to include over 800,000 products from numerous manufacturers, catering to research institutions, universities, and global pharmaceutical companies. The company emphasizes quality and customer service, maintaining a robust online presence for international business​.
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BOC Sciences

U.S.A
BIO Partnering at JPM
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BOC Sciences

U.S.A
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Aficamten

About the Company : BOC Sciences is a brand of BOCSCI Inc. We leverage our wide spectrum of business in the fields of development, manufacturing, marketing, and distribution to help you make best-info...

BOC Sciences is a brand of BOCSCI Inc. We leverage our wide spectrum of business in the fields of development, manufacturing, marketing, and distribution to help you make best-informed decisions tailored to your evolving needs for premium chemicals. Our complete suite of CRO services spans the entire molecule development pipeline including contract research for target identification, building blocks, compound synthesis, biochemical and cellular analysis, preclinical animal tests, and clinical studies.
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EOS Med Chem

China
BIO Partnering at JPM
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EOS Med Chem

China
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Aficamten

About the Company : EOS Med Chem build in 2008, 2018 Obtained third-party venture capital, 10 million US dollars. Now EOS Med Chem have one R&D about 1000㎡, in Jinan Life Science Park. One GMP st...

EOS Med Chem build in 2008, 2018 Obtained third-party venture capital, 10 million US dollars. Now EOS Med Chem have one R&D about 1000㎡, in Jinan Life Science Park. One GMP standard plant in Shanghe country, National Biopharmaceutical Park. Approved by TEVA, HIKMA, CIPLA, SUNPHARMA, WUXIAPP and some others. EOS Med Chem from the 2008 is aim to be World top CMO supplier, now TOP100 Pharma company, EOS Med Chem is serving 35. Mid-Size Pharma company more than 100. Lab company more than 500.
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GLP Bio

U.S.A
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GLP Bio

U.S.A
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Aficamten

About the Company : Glpbio Technology Inc is a leading supplier specializing in small molecule inhibitors, activators, compound libraries, peptides, and laboratory reagents. With a vast inventory of o...

Glpbio Technology Inc is a leading supplier specializing in small molecule inhibitors, activators, compound libraries, peptides, and laboratory reagents. With a vast inventory of over 30,000 products spanning more than 20 research fields including cancer, immunology, neurosciences, apoptosis, and epigenetics, Glpbio offers a comprehensive range of solutions for scientific research. Our commitment to quality and innovation ensures that researchers worldwide have access to high-quality tools and compounds essential for advancing discoveries in biomedicine and beyond.
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BIO Partnering at JPM
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Aficamten

About the Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom synthesis and manufact...

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Aficamten

About the Company : Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states...

Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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Drugs in Development

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Details:

Aficamten, a miscellaneous product targeting cardiac myosin, shows promise in treating New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (oHCM).


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Myqorzo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Sanofi

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 17, 2025

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Cytokinetics

U.S.A
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Cytokinetics

U.S.A
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BIO Partnering at JPM
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Details : Aficamten, a miscellaneous product targeting cardiac myosin, shows promise in treating New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Product Name : Myqorzo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 17, 2025

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Details:

Cytokinetics intends to use the net proceeds to support the potential commercial launch of aficamten, a cardiac myosin inhibitor, being developed for obstructive hypertrophic cardiomyopathy.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: CK-3773274

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: $550.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement September 16, 2025

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02

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : Cytokinetics intends to use the net proceeds to support the potential commercial launch of aficamten, a cardiac myosin inhibitor, being developed for obstructive hypertrophic cardiomyopathy.

Product Name : CK-3773274

Product Type : Miscellaneous

Upfront Cash : Undisclosed

September 16, 2025

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Details:

BAY3723113 (Aficamten) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Cardiomyopathy, Hypertrophic.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: BAY3723113

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 17, 2025

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03

Bayer AG

Germany
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BIO Partnering at JPM
Not Confirmed

Bayer AG

Germany
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BIO Partnering at JPM
Not Confirmed

Details : BAY3723113 (Aficamten) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Cardiomyopathy, Hypertrophic.

Product Name : BAY3723113

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 17, 2025

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Details:

CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor, being developed in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 13, 2025

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04

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor, being developed in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 13, 2025

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Details:

CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor. It is under phase 3 clinical development fot the treatment of obstructive hypertrophic cardiomyopathy.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 23, 2024

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Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Details : CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor. It is under phase 3 clinical development fot the treatment of obstructive hypertrophic cardiomyopathy.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 23, 2024

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Details:

Sanofi will acquire CORXEL’s rights relating to CK-3773274 (aficamten) in Greater China> It is being evaluated for the treatment of obstructive and non-obstructive hypertrophic cardiomyopathy.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Sanofi

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition December 20, 2024

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06

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : Sanofi will acquire CORXEL’s rights relating to CK-3773274 (aficamten) in Greater China> It is being evaluated for the treatment of obstructive and non-obstructive hypertrophic cardiomyopathy.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

December 20, 2024

blank

Details:

CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor. It is under development for the treatment of obstructive hypertrophic cardiomyopathy.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 02, 2024

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07

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Cytokinetics

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor. It is under development for the treatment of obstructive hypertrophic cardiomyopathy.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 02, 2024

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Details:

The agreement aims for the development and commercialization of aficamten, a next-in-class cardiac myosin inhibitor, in Japan for the treatment of patients with obstructive and non-obstructive HCM.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Bayer AG

Deal Size: $630.0 million Upfront Cash: $52.0 million

Deal Type: Collaboration November 19, 2024

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08

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Cytokinetics

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : The agreement aims for the development and commercialization of aficamten, a next-in-class cardiac myosin inhibitor, in Japan for the treatment of patients with obstructive and non-obstructive HCM.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : $52.0 million

November 19, 2024

blank

Details:

CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor. It is under clinical development for the treatment of obstructive hypertrophic cardiomyopathy.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 17, 2024

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09

Cytokinetics

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Cytokinetics

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : CK-3773274 (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor. It is under clinical development for the treatment of obstructive hypertrophic cardiomyopathy.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 17, 2024

blank

Details:

The company will use the proceeds for commercial launch readiness activities and for development program of CK-3773274 (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy.


Lead Product(s): Aficamten,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: J.P. Morgan

Deal Size: $500.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 28, 2024

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10

Cytokinetics

U.S.A
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BIO Partnering at JPM
Not Confirmed

Cytokinetics

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : The company will use the proceeds for commercial launch readiness activities and for development program of CK-3773274 (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

May 28, 2024

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FDF Dossiers

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AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 219083

Regulatory Info :

Registration Country : USA

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AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 219083

Regulatory Info :

Registration Country : USA

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AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number : 219083

Regulatory Info :

Registration Country : USA

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AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 219083

Regulatory Info :

Registration Country : USA

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FDA Orange Book

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CYTOKINETICS INC

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CYTOKINETICS INC

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Not Confirmed

AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 5MG

Approval Date :

Application Number : 219083

RX/OTC/DISCN :

RLD :

TE Code :

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02

CYTOKINETICS INC

Country
BIO Partnering at JPM
Not Confirmed
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CYTOKINETICS INC

Country
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BIO Partnering at JPM
Not Confirmed

AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 10MG

Approval Date :

Application Number : 219083

RX/OTC/DISCN :

RLD :

TE Code :

blank

03

CYTOKINETICS INC

Country
BIO Partnering at JPM
Not Confirmed
arrow

CYTOKINETICS INC

Country
arrow
BIO Partnering at JPM
Not Confirmed

AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 15MG

Approval Date :

Application Number : 219083

RX/OTC/DISCN :

RLD :

TE Code :

blank

04

CYTOKINETICS INC

Country
BIO Partnering at JPM
Not Confirmed
arrow

CYTOKINETICS INC

Country
arrow
BIO Partnering at JPM
Not Confirmed

AFICAMTEN

Brand Name : MYQORZO

Dosage Form : TABLET:FILM COATED

Dosage Strength : 20MG

Approval Date :

Application Number : 219083

RX/OTC/DISCN :

RLD :

TE Code :

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ABOUT THIS PAGE

Looking for 2364554-48-1 / Aficamten API manufacturers, exporters & distributors?

Aficamten manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aficamten manufacturer or Aficamten supplier.

PharmaCompass also assists you with knowing the Aficamten API Price utilized in the formulation of products. Aficamten API Price is not always fixed or binding as the Aficamten Price is obtained through a variety of data sources. The Aficamten Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Aficamten

Synonyms

Aficamten [inn], Aficamten [usan], 2364554-48-1, B1i77mh6k1, Chembl4847050, Ck-3773274

Cas Number

2364554-48-1

Unique Ingredient Identifier (UNII)

B1I77MH6K1

Aficamten Manufacturers

A Aficamten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aficamten, including repackagers and relabelers. The FDA regulates Aficamten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aficamten 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 Aficamten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Aficamten Suppliers

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

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

Aficamten 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 Aficamten as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Aficamten 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 Aficamten 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 Aficamten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aficamten NDC to their finished compounded human drug products, they may choose to do so.

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

Aficamten GMP

Aficamten 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 Aficamten 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 Aficamten GMP manufacturer or Aficamten GMP API supplier for your needs.

Aficamten CoA

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

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

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