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1. (6r)-6-(2-(ethyl((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol
1. 722533-56-4
2. Rad1901
3. Elacestrant [inn]
4. Elacestrant [usan]
5. Rad-1901
6. Er-306323
7. Fm6a2627a8
8. (6r)-6-[2-[ethyl-[[4-[2-(ethylamino)ethyl]phenyl]methyl]amino]-4-methoxyphenyl]-5,6,7,8-tetrahydronaphthalen-2-ol
9. (6r)-6-{2-[ethyl({4-[2-(ethylamino)ethyl]phenyl}methyl)amino]-4-methoxyphenyl}-5,6,7,8-tetrahydronaphthalen-2-ol
10. (2r)-2-(2-(ethyl-((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxy-phenyl)tetralin-6-ol
11. (6r)-6-(2-(ethyl((4-(2- (ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)- 5,6,7,8-tetrahydronaphthalen-2-ol
12. 2-naphthalenol, 6-(2-(ethyl((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydro-, (6r)-
13. Elacestrant (usan/inn)
14. Elacestrant [usan:inn]
15. Elacestrant [who-dd]
16. Schembl229431
17. Unii-fm6a2627a8
18. Chembl4297509
19. Bdbm349630
20. Dtxsid901045846
21. Glxc-26208
22. Ex-a5070
23. Us10208011, Compound Rad-
24. Mfcd30532693
25. Who 10247
26. Cs-6306
27. Db06374
28. Hy-19822
29. D11671
30. Q27278069
31. (r)-6-(2-(ethyl(4-(2-(ethylamino)ethyl)benzyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol
32. I0v
| Molecular Weight | 458.6 g/mol |
|---|---|
| Molecular Formula | C30H38N2O2 |
| XLogP3 | 6.3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 10 |
| Exact Mass | 458.293328459 g/mol |
| Monoisotopic Mass | 458.293328459 g/mol |
| Topological Polar Surface Area | 44.7 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 578 |
| 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 |
Investigated for use/treatment in menopause and female hormonal deficiencies/abnormalities.
RAD1901 is a novel selective estrogen receptor modulator(SERM). SERMs are small molecules that bind to and selectively modulate estrogen receptors. These molecules have the ability to stimulate or block estrogen's activity in different types of tissue, functioning as estrogen receptor agonists in some tissues and as estrogen receptor antagonists in others. RAD1901 has potential to reduce vasomotor symptoms, along with a simultaneous bone-protective effect, without stimulating breast or uterine tissues. RAD1901 is distinctive from other SERMs in its unique biological profile, combined with its significant ability to penetrate the blood-brain barrier, which enables RAD1901 to function as an estrogen agonist within the central nervous system and thereby relieve hot flashes.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41578
Submission : 2025-03-26
Status : Active
Type : II





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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41578
Submission : 2025-03-26
Status : Active
Type : II

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

About the Company : Apino Pharma prides itself on being an innovation-driven company that strives to continuously improve its products and services. Our dedicated innovation team collaborates with the...

About the Company : Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing p...

About the Company : Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and...

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Elacestrant is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of uterine neoplasms.
Lead Product(s): Elacestrant,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Stemline Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 12, 2026

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Lead Product(s) : Elacestrant,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Stemline Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Ph 2 Elacestrant in ER Positive Uterine Sarcomas
Details : Elacestrant is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of uterine neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 12, 2026

Details:
Elacestrant is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Elacestrant,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Berlin-Chemie Menarini
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2025

Lead Product(s) : Elacestrant,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Berlin-Chemie Menarini
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Elacestrant is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 21, 2025

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Capecitabine is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Capecitabine,Elacestrant
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Menarini | Johns Hopkins University | Translational Breast Cancer Research Consortium | Kristina A. Fanucci
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 29, 2025

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Lead Product(s) : Capecitabine,Elacestrant
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Menarini | Johns Hopkins University | Translational Breast Cancer Research Consortium | Kristina A. Fanucci
Deal Size : Inapplicable
Deal Type : Inapplicable
CAPELA Study of Capecitabine + Elacestrant in ER+ Breast Cancer
Details : Capecitabine is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 29, 2025

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Elacestrant is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Elacestrant,Trastuzumab Deruxtecan
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Stemline Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 30, 2025

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Lead Product(s) : Elacestrant,Trastuzumab Deruxtecan
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Stemline Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Elacestrant is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 30, 2025

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Elacestrant is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Elacestrant,Leuprolide Acetate
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 08, 2025

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Lead Product(s) : Elacestrant,Leuprolide Acetate
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Elacestrant is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 08, 2025

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Elacestrant is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Elacestrant,Onapristone
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2025

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Lead Product(s) : Elacestrant,Onapristone
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Elacestrant is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2025

Details:
Elacestrant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Elacestrant,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Johns Hopkins University | Stemline Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 11, 2025

Lead Product(s) : Elacestrant,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Johns Hopkins University | Stemline Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
ctDNA Guided Adjuvant Treatment With Elacestrant: TBCRC-068
Details : Elacestrant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 11, 2025

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Elacestrant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Elacestrant,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 09, 2024

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

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Everolimus is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Everolimus,Elacestrant,Dexamethasone,Luteinizing Hormone Releasing Hormone Analog
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Stemline Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 24, 2024

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Lead Product(s) : Everolimus,Elacestrant,Dexamethasone,Luteinizing Hormone Releasing Hormone Analog
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Stemline Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Everolimus is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 24, 2024

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Rupitasertib is an oral inhibitor of S6K and AKT1/AKT3 designed to block the PI3K/AKT/mTOR pathway, being investigated with elacestrant in ER+/HER2- advanced breast cancer with ESR1 mutation.
Lead Product(s): Rupitasertib,Elacestrant
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2024

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Lead Product(s) : Rupitasertib,Elacestrant
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evexta Bio Reports Progress On Rupitasertib for Advanced Breast Cancer
Details : Rupitasertib is an oral inhibitor of S6K and AKT1/AKT3 designed to block the PI3K/AKT/mTOR pathway, being investigated with elacestrant in ER+/HER2- advanced breast cancer with ESR1 mutation.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2024

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]6-(benzyloxy)-3,4-dihydronaphthalen-1(2H)-one
CAS Number : 32263-70-0
End Use API : Elacestrant
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

6-(benzyloxy)-3,4-dihydronaphthalen-1(2H)-one
CAS Number : 32263-70-0
End Use API : Elacestrant
About The Company : Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the ...

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09 Dec 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/menarini-group-presents-elacestrant-orserdu-phase-2-combination-data-in-patients-with-er-her2--metastatic-breast-cancer-mbc-at-the-2025-san-antonio-breast-cancer-symposium-302635656.html

22 May 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/05/22/3087170/21662/en/Menarini-Group-Presents-Updated-Data-Underscoring-the-Combinability-of-Elacestrant-ORSERDU-in-Patients-with-ER-HER2-Metastatic-Breast-Cancer-mBC-at-the-ASCO-2025-Annual-Meeting.html

26 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/menarini-group-presents-new-and-expanded-data-at-the-2024-san-antonio-breast-cancer-symposium-reinforcing-the-role-of-orserdu-elacestrant-for-patients-with-er-her2--advanced-or-metastatic-breast-cancer-mbc-302316326.html

25 Nov 2024
// BUSINESSWIRE

23 May 2024
// BUSINESSWIRE

22 May 2024
// BUSINESSWIRE
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PharmaCompass offers a list of Elacestrant 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 Elacestrant manufacturer or Elacestrant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Elacestrant manufacturer or Elacestrant supplier.
A Elacestrant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elacestrant, including repackagers and relabelers. The FDA regulates Elacestrant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elacestrant 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 Elacestrant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Elacestrant supplier is an individual or a company that provides Elacestrant active pharmaceutical ingredient (API) or Elacestrant finished formulations upon request. The Elacestrant suppliers may include Elacestrant API manufacturers, exporters, distributors and traders.
click here to find a list of Elacestrant suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Elacestrant DMF (Drug Master File) is a document detailing the whole manufacturing process of Elacestrant active pharmaceutical ingredient (API) in detail. Different forms of Elacestrant DMFs exist exist since differing nations have different regulations, such as Elacestrant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elacestrant DMF submitted to regulatory agencies in the US is known as a USDMF. Elacestrant USDMF includes data on Elacestrant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elacestrant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elacestrant suppliers with USDMF on PharmaCompass.
Elacestrant 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 Elacestrant GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Elacestrant GMP manufacturer or Elacestrant GMP API supplier for your needs.
A Elacestrant CoA (Certificate of Analysis) is a formal document that attests to Elacestrant's compliance with Elacestrant specifications and serves as a tool for batch-level quality control.
Elacestrant CoA mostly includes findings from lab analyses of a specific batch. For each Elacestrant 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.
Elacestrant may be tested according to a variety of international standards, such as European Pharmacopoeia (Elacestrant EP), Elacestrant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elacestrant USP).