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    Chemistry

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    Also known as: Odm-201, 1297538-32-9, Bay-1841788, Nubeqa, Bay1841788, Darolutamide [usan]
    Molecular Formula
    C19H19ClN6O2
    Molecular Weight
    398.8  g/mol
    InChI Key
    BLIJXOOIHRSQRB-PXYINDEMSA-N
    FDA UNII
    X05U0N2RCO
    Darolutamide
    Darolutamide is a formulation containing an androgen receptor (AR) antagonist with potential antineoplastic activity. Darolutamide binds to ARs in target tissues; subsequently, inhibiting androgen-induced receptor activation and facilitating the formation of inactive complexes that cannot translocate to the nucleus. This prevents binding to and transcription of AR-responsive genes that regulate prostate cancer cell proliferation. This ultimately leads to an inhibition of growth in AR-expressing prostate cancer cells.
    1 2D Structure

    Darolutamide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[(2S)-1-[3-(3-chloro-4-cyanophenyl)pyrazol-1-yl]propan-2-yl]-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide
    2.1.2 InChI
    InChI=1S/C19H19ClN6O2/c1-11(22-19(28)18-8-17(12(2)27)23-24-18)10-26-6-5-16(25-26)13-3-4-14(9-21)15(20)7-13/h3-8,11-12,27H,10H2,1-2H3,(H,22,28)(H,23,24)/t11-,12?/m0/s1
    2.1.3 InChI Key
    BLIJXOOIHRSQRB-PXYINDEMSA-N
    2.1.4 Canonical SMILES
    CC(CN1C=CC(=N1)C2=CC(=C(C=C2)C#N)Cl)NC(=O)C3=NNC(=C3)C(C)O
    2.1.5 Isomeric SMILES
    C[C@@H](CN1C=CC(=N1)C2=CC(=C(C=C2)C#N)Cl)NC(=O)C3=NNC(=C3)C(C)O
    2.2 Other Identifiers
    2.2.1 UNII
    X05U0N2RCO
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Nubeqa

    2. Odm-201

    3. Orm-16497

    4. Orm-16555

    2.3.2 Depositor-Supplied Synonyms

    1. Odm-201

    2. 1297538-32-9

    3. Bay-1841788

    4. Nubeqa

    5. Bay1841788

    6. Darolutamide [usan]

    7. N-((s)-1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl)propan-2-yl)-5-(1-hydroxyethyl)-1h-pyrazole-3-carboxamide

    8. Bay 1841788

    9. X05u0n2rco

    10. Odm-201;bay-1841788

    11. 1h-pyrazole-3-carboxamide, N-((1s)-2-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl)-1-methylethyl)-5-(1-hydroxyethyl)-

    12. N-((s)-1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl)-propan-2-yl)-3-(1-hydroxyethyl)-1h-pyrazole-5-carboxamide

    13. Odm201

    14. 1h-pyrazole-3-carboxamide, N-[(1s)-2-[3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl]-1-methylethyl]-5-(1-hydroxyethyl)-

    15. Nebeqa (tn)

    16. Darolutamide [mi]

    17. Odm-201(darolutamide)

    18. Darolutamide [inn]

    19. Darolutamide [jan]

    20. Unii-x05u0n2rco

    21. Darolutamide (odm-201)

    22. Darolutamide [who-dd]

    23. Darolutamide (jan/usan/inn)

    24. Schembl1814935

    25. Chembl4297185

    26. Schembl13733117

    27. Gtpl10439

    28. Ex-a759

    29. Bdbm309979

    30. Darolutamide [orange Book]

    31. Dtxsid101027953

    32. Example 56 [us9657003]

    33. N-[(2s)-1-[3-(3-chloro-4-cyanophenyl)pyrazol-1-yl]propan-2-yl]-5-(1-hydroxyethyl)-1h-pyrazole-3-carboxamide

    34. Bdbm50556205

    35. Mfcd29472270

    36. Nsc825331

    37. Akos030526387

    38. Ccg-268640

    39. Cs-5174

    40. Db12941

    41. Nsc-825331

    42. Ncgc00484078-01

    43. Ac-32628

    44. As-75032

    45. Bay-1841788)

    46. Hy-16985

    47. S7559

    48. J3.501.129c

    49. D11045

    50. Us9657003, 56

    51. A888821

    52. J-690121

    53. Q25091391

    54. 1-[(2s)-2-butanyl]-n-[(4,6-dimethyl-2-oxo-1,2-dihydro-3-pyridinyl)methyl]-3-methyl-6-[6-(1-piperazinyl)-3-pyridinyl]-1h-indole-4-car Boxamide

    55. N-((2s)-1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol- 1-yl)propan-2-yl)-5-((1rs)-1-hydroxyethyl)-1h-pyrazole- 3-carboxamide

    56. N-((2s)-1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl)propan-2-yl)-5-((1rs)-1-hydroxyethyl)-1h-pyrazole-3-carboxamide

    57. N-((s)-1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol -1-yl)propan-2-yl)-3-(1-hydroxyethyl)-1h-pyrazole-5-carboxamide

    58. N-((s)-1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl)propan-2-yl)-5-(1-hydroxy-ethyl)-1h-pyrazole-3-carboxamide

    59. N-[(2s)-1-[3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl]propan-2-yl]-5-(1-hydroxyethyl)-1h-pyrazole-3-carboxamide

    2.4 Create Date
    2012-11-30
    3 Chemical and Physical Properties
    Molecular Weight 398.8 g/mol
    Molecular Formula C19H19ClN6O2
    XLogP31.8
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass398.1258016 g/mol
    Monoisotopic Mass398.1258016 g/mol
    Topological Polar Surface Area120 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity598
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    This drug is indicated for the treatment of patients diagnosed with non-metastatic and castrate-resistant prostate cancer.

    FDA Label

    Nubeqa is indicated for the treatment of adult men with non metastatic castration resistant prostate cancer (nmCRPC) who are at risk of developing metastatic disease.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Darolutamide, through its downstream effects on cancer cell growth, treats castrate-resistant prostate cancer. It inhibits cancer cell growth and markedly lowers prostate specific antigen (PSA) levels through potent androgen receptor antagonism.

    5.2 ATC Code

    L02BB

    L - Antineoplastic and immunomodulating agents

    L02 - Endocrine therapy

    L02B - Hormone antagonists and related agents

    L02BB - Anti-androgens

    L02BB06 - Darolutamide

    5.3 Absorption, Distribution and Excretion

    Absorption

    Darolutamide is absorbed in the gastrointestinal tract. In the fasted state, peak concentrations are reached within 3-5 hours, and within 3-8 hours in the fed state. Median Tmax is between 3-6 hours.The average darolutamide steady-state peak plasma concentration after a 600 mg twice daily dose is approximately 4.79 mg/L. The Cmax is attained approximately 4 hours after administration of a single 600 mg oral dose. The AUC 0-12h is approximately 52.82 hg/mL. **Effects of food** The absolute bioavailability of darolutamide is approximately 30% after fasting and taking a single 300 mg dose. Steady-state concentrations are attained between 2 and 5 days after repeated administration with food. The bioavailability of darolutamide increases by 2.0 to 2.5 times when it is given with food.

    Route of Elimination

    In a pharmacokinetic study, a radiolabeled dose of darolutamide in an oral solution showed that 63.4% of darolutamide-related material was excreted in the urine (7% of which was unchanged drug) and 32.4% in the feces (with 30% unchanged drug).

    Volume of Distribution

    After intravenous administration, the apparent volume of distribution of darolutamide is about 119L.

    Clearance

    The clearance of darolutamide after an intravenous dose is 116 mL/min (39.7%).

    5.4 Metabolism/Metabolites

    Darolutamide is mainly metabolized by the CYP3A4 hepatic microsomal enzyme in addition to UGT1A9 and UGT1A1. The main active metabolite keto-darolutamide in found in the plasma at 2 times the concentration of darolutamide.

    5.5 Biological Half-Life

    The half-life of darolutamide and its active metabolite, keto-darolutamide is about 20 hours. A phase 1 study determined a terminal half life ranging between 10-15 hours.

    5.6 Mechanism of Action

    The actions of androgens on androgen receptors (AR) potentiate the growth and survival of prostate cancer cells. Darolutamide competitively inhibits androgens from binding to their receptors, inhibiting AR nuclear translocation, as well as AR-mediated transcription. The end result of these processes is a decrease in prostate cancer cell proliferation and tumor size. Its main metabolite, keto-darolutamide, shows similar pharmacological activity to the parent drug, darolutamide. Darolutamide has been found to bind more tightly to the AR receptor than [apalutamide] and [enzalutamide], which are other androgen receptor antagonists. Darolutamide can act as a progesterone receptor (PR) antagonist in the laboratory setting with approximately 1% activity when compared to its actions at the androgen receptor. The clinical relevance is not known at this time.

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    Drugs in Development

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    Orion and Bayer Expand Clinical Development Program for Darolutamide in Prostate Cancer

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Bayer AG

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 23, 2023

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    Orion Corporation

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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Orion and Bayer Expand Clinical Development Program for Darolutamide in Prostate Cancer

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 23, 2023

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    Darolutamide Approved for Additional Prostate Cancer Indication in China

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 20, 2023

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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Darolutamide Approved for Additional Prostate Cancer Indication in China

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 20, 2023

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    Darolutamide Receives EU Approval for Additional Indication in Prostate Cancer

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 01, 2023

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    03

    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Darolutamide Receives EU Approval for Additional Indication in Prostate Cancer

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 01, 2023

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    Darolutamide Receives Approval for Additional Prostate Cancer Indication in Japan

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Bayer AG

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 27, 2023

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    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Darolutamide Receives Approval for Additional Prostate Cancer Indication in Japan

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 27, 2023

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    Positive CHMP Opinion for Darolutamide in Combination with Docetaxel for The Treatment of Metastatic Hormone-Sensitive Prostate Cancer

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 27, 2023

    Fermion Orion Company Banner

    05

    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Positive CHMP Opinion for Darolutamide in Combination with Docetaxel for The Treatment of Metastat...

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of pros...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 27, 2023

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    The FDA Approves the Use of Darolutamide in Combination with Docetaxel as An Additional Indication in The Treatment of Metastatic Hormone-Sensitive Pros...

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 08, 2022

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    06

    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    The FDA Approves the Use of Darolutamide in Combination with Docetaxel as An Additional Indication...

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cance...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 08, 2022

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    The US Food and Drug Administration (FDA) Accepts a New Supplemental Marketing Authorization Application for the Additional Indication for Darolutamide ...

    Details:

    The sNDA is based on positive results from pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival for Nubeqa (darolutamide) plus androgen deprivation therapy and docetaxel in men with mHSPC compared to ADT plus docetaxel.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Bayer AG

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 03, 2022

    Fermion Orion Company Banner

    07

    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    The US Food and Drug Administration (FDA) Accepts a New Supplemental Marketing Authorization Appli...

    Details : The sNDA is based on positive results from pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival for Nubeqa (darolutamide) plus androgen deprivation therapy and docetaxel in men with mHSPC compared to A...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 03, 2022

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    Orion Plans to Focus Research and Product Development - In The Future on Cancer and Pain

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 24, 2022

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    08

    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Orion Plans to Focus Research and Product Development - In The Future on Cancer and Pain

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cance...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 24, 2022

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    Orion and Bayer Are Expanding the Darolutamide Development Program in The Area of ​​prostate Cancer

    Details:

    Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Bayer AG

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 08, 2022

    Fermion Orion Company Banner

    09

    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Orion and Bayer Are Expanding the Darolutamide Development Program in The Area of ​​prostate C...

    Details : Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cance...

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 08, 2022

    Fermion Orion Company Banner

    Stock Recap
    #PipelineProspector

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    ARASENS Trial with Darolutamide in Combination with Docetaxel and Androgen Deprivation Therapy Meets Primary Endpoint of Significantly Increasing Overal...

    Details:

    The ARASENS trial, Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy significantly increased overall survival for patients with metastatic hormone-sensitive prostate cancer.


    Lead Product(s): Darolutamide,Docetaxel

    Therapeutic Area: Oncology Brand Name: Nubeqa

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Bayer AG

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 03, 2021

    Fermion Orion Company Banner

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    Orion Corporation

    Finland
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    Lead Product(s) : Darolutamide,Docetaxel

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Bayer AG

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ARASENS Trial with Darolutamide in Combination with Docetaxel and Androgen Deprivation Therapy Mee...

    Details : The ARASENS trial, Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy significantly increased overall survival for patients with metastatic hormone-sensitive prostate cancer.

    Brand Name : Nubeqa

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 03, 2021

    Fermion Orion Company Banner

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    INTERMEDIATES SUPPLIERS

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    01

    Aarti Pharmalabs

    India
    CPhI India 2024
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    2-Chloro-4-(1H-pyrazol-5-yl) benzo nitrile

    CAS Number : 1297537-37-1

    End Use API : Darolutamide

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

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    02

    Shandong Loncom Pharmaceutical

    China
    American Pharma Summit
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    Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

    1H-Pyrazole-3-Carboxylic Acid, 5-(Acetylamino)

    CAS Number : 949034-45-1

    End Use API : Darolutamide

    About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...

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    FDA Orange Book

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    BAYER HEALTHCARE

    Germany
    Compamed
    Not Confirmed
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    BAYER HEALTHCARE

    Germany
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    RLD : Yes

    TE Code :

    DAROLUTAMIDE

    Brand Name : NUBEQA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG

    Approval Date : 2019-07-30

    Application Number : 212099

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    Europe

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    Bayer (Schweiz) AG

    Germany
    Compamed
    Not Confirmed
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    Bayer (Schweiz) AG

    Germany
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    Regulatory Info :

    Registration Country : Switzerland

    Darolutamide

    Brand Name : Nubeqa

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 300mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Canada

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    BAYER INC

    Germany
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    BAYER INC

    Germany
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    Regulatory Info : Prescription

    Registration Country : Canada

    DAROLUTAMIDE

    Brand Name : NUBEQA

    Dosage Form : TABLET

    Dosage Strength : 300MG

    Packaging :

    Approval Date :

    Application Number : 2496348

    Regulatory Info : Prescription

    Registration Country : Canada

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    Australia

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    Bayer Australia Ltd

    Germany
    Compamed
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    Bayer Australia Ltd

    Germany
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    Regulatory Info :

    Registration Country : Australia

    darolutamide

    Brand Name : Nubeqa

    Dosage Form :

    Dosage Strength :

    Packaging : 112

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    02

    Bayer Australia Ltd

    Germany
    Compamed
    Not Confirmed
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    Bayer Australia Ltd

    Germany
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    Regulatory Info :

    Registration Country : Australia

    darolutamide

    Brand Name : Nubeqa

    Dosage Form :

    Dosage Strength :

    Packaging : 112

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    South Africa

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    Bayer (Pty) Ltd

    Germany
    Compamed
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    Bayer (Pty) Ltd

    Germany
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    Regulatory Info : Originator

    Registration Country : South Africa

    Darolutamide

    Brand Name : NUBEQA

    Dosage Form : TAB

    Dosage Strength : 300mg

    Packaging : 112X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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