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    Chemistry

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    Also known as: Lurasidone hcl, 367514-88-3, Latuda, Sm-13496, Lurasidone hydrochloride [usan], Sm 13496
    Molecular Formula
    C28H37ClN4O2S
    Molecular Weight
    529.1  g/mol
    InChI Key
    NEKCRUIRPWNMLK-SCIYSFAVSA-N
    FDA UNII
    O0P4I5851I
    Lurasidone Hydrochloride
    A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic 2A and 2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.
    1 2D Structure

    Lurasidone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,2R,6S,7R)-4-[[(1R,2R)-2-[[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione;hydrochloride
    2.1.2 InChI
    InChI=1S/C28H36N4O2S.ClH/c33-27-24-18-9-10-19(15-18)25(24)28(34)32(27)17-21-6-2-1-5-20(21)16-30-11-13-31(14-12-30)26-22-7-3-4-8-23(22)35-29-26;/h3-4,7-8,18-21,24-25H,1-2,5-6,9-17H2;1H/t18-,19+,20-,21-,24+,25-;/m0./s1
    2.1.3 InChI Key
    NEKCRUIRPWNMLK-SCIYSFAVSA-N
    2.1.4 Canonical SMILES
    C1CCC(C(C1)CN2CCN(CC2)C3=NSC4=CC=CC=C43)CN5C(=O)C6C7CCC(C7)C6C5=O.Cl
    2.1.5 Isomeric SMILES
    C1CC[C@H]([C@@H](C1)CN2CCN(CC2)C3=NSC4=CC=CC=C43)CN5C(=O)[C@H]6[C@@H]7CC[C@@H](C7)[C@H]6C5=O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    O0P4I5851I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 13496, Sm

    2. Hcl, Lurasidone

    3. Hydrochloride, Lurasidone

    4. Latuda

    5. Lurasidone

    6. Lurasidone Hcl

    7. N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide

    8. Sm 13,496

    9. Sm 13496

    10. Sm-13,496

    11. Sm-13496

    12. Sm13,496

    13. Sm13496

    2.3.2 Depositor-Supplied Synonyms

    1. Lurasidone Hcl

    2. 367514-88-3

    3. Latuda

    4. Sm-13496

    5. Lurasidone Hydrochloride [usan]

    6. Sm 13496

    7. Chebi:70732

    8. O0p4i5851i

    9. Lurasidonhydrochloride

    10. (1s,2r,6s,7r)-4-[[(1r,2r)-2-[[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione;hydrochloride

    11. (3ar,4s,7r,7as)-2-(((1r,2r)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione Hydrochloride

    12. (1r,2s,6r,7s)-4-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0^{2,6}]decane-3,5-dione Hydrochloride

    13. 4,7-methano-1h-isoindole-1,3(2h)-dione, 2-(((1r,2r)-2-((4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)methyl)cyclohexyl)methyl)hexahydro-, Monohydrochloride, (3ar,4s,7r,7as)-

    14. Unii-o0p4i5851i

    15. Latuda (tn)

    16. Lurasidone Monohydrochloride

    17. Lurasidone-d8 Hydrochloride

    18. Sm-13496 (hydrochloride)

    19. Schembl1534132

    20. Chembl1615372

    21. Dtxsid401027714

    22. Lurasidone Hydrochloride (jan/usan)

    23. Lurasidone Hydrochloride [mi]

    24. S3044

    25. Smp-13496

    26. Lurasidone Hydrochloride [jan]

    27. Akos022185856

    28. Ex-3125

    29. Mk-3756

    30. Lurasidone Hydrochloride [mart.]

    31. Lurasidone Hydrochloride [vandf]

    32. Lurasidone Hydrochloride [who-dd]

    33. As-35074

    34. Lurasidone Hydrochloride, >=98% (hplc)

    35. Lurasidone Hydrochloride [orange Book]

    36. D04820

    37. Q27882070

    38. (3ar,4s,7r,7as)-2-((1r,2r)-2-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2h-isoindole-1,3-dione, Hydrochloride

    39. (3ar,4s,7r,7as)-2-{(1r,2r)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2h-isoindole-1,3-dione Hydrochloride

    40. (3ar,4s,7r,7as)-2-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione Hydrochloride

    41. 4-(1,2-benzothiazol-3-yl)-1-{[(1r,2r)-2-{[(3ar,4s,7r,7as)-1,3-dioxooctahydro-2h-4,7-methanoisoindol-2-yl]methyl}cyclohexyl]methyl}piperazin-1-ium Chloride

    42. Lurasidone Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 529.1 g/mol
    Molecular Formula C28H37ClN4O2S
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass528.2325753 g/mol
    Monoisotopic Mass528.2325753 g/mol
    Topological Polar Surface Area85 Ų
    Heavy Atom Count36
    Formal Charge0
    Complexity804
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameLatuda
    PubMed HealthLurasidone (By mouth)
    Drug ClassesAntipsychotic, Central Nervous System Agent
    Drug LabelLATUDA is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3...
    Active IngredientLurasidone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength120mg; 60mg; 80mg; 40mg; 20mg
    Market StatusPrescription
    CompanySunovion Pharms

    2 of 2  
    Drug NameLatuda
    PubMed HealthLurasidone (By mouth)
    Drug ClassesAntipsychotic, Central Nervous System Agent
    Drug LabelLATUDA is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3...
    Active IngredientLurasidone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength120mg; 60mg; 80mg; 40mg; 20mg
    Market StatusPrescription
    CompanySunovion Pharms

    4.2 Drug Indication

    Treatment of schizophrenia in adults aged 18 years and over.

    Treatment of schizophrenia

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Adrenergic alpha-2 Receptor Antagonists

    Drugs that bind to and block the activation of ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Antagonists.)

    Antipsychotic Agents

    Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)

    Dopamine D2 Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of DOPAMINE D2 RECEPTORS. (See all compounds classified as Dopamine D2 Receptor Antagonists.)

    Serotonin 5-HT2 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes. (See all compounds classified as Serotonin 5-HT2 Receptor Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Atypical Antipsychotic [EPC]
    5.3 ATC Code

    N05AE05

    API Reference Price

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    25-Jan-2022
    16-Sep-2025
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    Drugs in Development

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    Sunshine Biopharma Launches Generic Lurasidone for Schizophrenia in Canada

    Details:

    Lurasidone HCl is a D2 and 5HT2A inhibitor, indicated for the management of schizophrenia and bipolar depression.


    Lead Product(s): Lurasidone Hydrochloride,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Latuda-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 06, 2025

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    01

    Nora Pharma

    Canada
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    BOS Manchester
    Not Confirmed

    Nora Pharma

    Canada
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    BOS Manchester
    Not Confirmed
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    Lead Product(s) : Lurasidone Hydrochloride,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sunshine Biopharma Launches Generic Lurasidone for Schizophrenia in Canada

    Details : Lurasidone HCl is a D2 and 5HT2A inhibitor, indicated for the management of schizophrenia and bipolar depression.

    Product Name : Latuda-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 06, 2025

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    NRx Reports Trial Results Showing Safety of NRX-101 in Suicidal Bipolar Depression

    Details:

    NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 06, 2024

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    02

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRx Reports Trial Results Showing Safety of NRX-101 in Suicidal Bipolar Depression

    Details : NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 06, 2024

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    NRx Announces Promising Findings in Phase 2b/3 of NRX-101 for Suicidal Bipolar Depression

    Details:

    NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 30, 2024

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    03

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRx Announces Promising Findings in Phase 2b/3 of NRX-101 for Suicidal Bipolar Depression

    Details : NRX-101 (D-cycloserine & Lurasidone HCl) is a fixed dose combination which is under clinical development for various indications including for the treatment of suicidal bipolar depression.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 30, 2024

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    NRx Reports NRX-101 Shows No Damage To Intestinal Flora

    Details:

    NRX-101 (D-cycloserine & Lurasidone HCl) shows no measurable damage to intestinal or vaginal flora in rodent models of urinary tract infections and associated complications.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 17, 2024

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    04

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRx Reports NRX-101 Shows No Damage To Intestinal Flora

    Details : NRX-101 (D-cycloserine & Lurasidone HCl) shows no measurable damage to intestinal or vaginal flora in rodent models of urinary tract infections and associated complications.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 17, 2024

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    NRx Pharmaceuticals Announces Last Patient, Last Visit in Phase 2b/3 Trial Of NRX-101

    Details:

    NRX-101, a combination of the NMDA antagonist D-cycloserine and lurasidone, is in phase 2/3 trials for treating resistant bipolar depression and suicidal ideation.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 04, 2024

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    05

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
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    U.S.A
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRx Pharmaceuticals Announces Last Patient, Last Visit in Phase 2b/3 Trial Of NRX-101

    Details : NRX-101, a combination of the NMDA antagonist D-cycloserine and lurasidone, is in phase 2/3 trials for treating resistant bipolar depression and suicidal ideation.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 04, 2024

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    NRx Pharmaceuticals Announces $5 Million Milestone from Alvogen and Lotus Pharma

    Details:

    The collaborations aim to support NRx for the development of NRX-101 (D-cycloserine) in the treatment of bipolar depression with suicidality.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Alvogen

    Deal Size: $345.0 million Upfront Cash: $10.0 million

    Deal Type: Collaboration February 11, 2024

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    06

    NRx Pharmaceuticals

    U.S.A
    arrow
    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Alvogen

    Deal Size : $345.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    NRx Pharmaceuticals Announces $5 Million Milestone from Alvogen and Lotus Pharma

    Details : The collaborations aim to support NRx for the development of NRX-101 (D-cycloserine) in the treatment of bipolar depression with suicidality.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : $10.0 million

    February 11, 2024

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    NRx Pharmaceuticals Completes Enrollment Of Phase 2b/3 Trial Of NRX-101

    Details:

    NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, is in phase 2/3 trials for treatment-resistant bipolar depression and suicidal ideation.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 22, 2024

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    07

    NRx Pharmaceuticals

    U.S.A
    arrow
    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRx Pharmaceuticals Completes Enrollment Of Phase 2b/3 Trial Of NRX-101

    Details : NRX-101, a fixed-dose combination of D-cycloserine and lurasidone, is in phase 2/3 trials for treatment-resistant bipolar depression and suicidal ideation.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 22, 2024

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    NRx Pharmaceuticals Announces FDA QIDP and Fast Track Designation for NRX-101

    Details:

    NRX-101 combines D-cycloserine and lurasidone, currently in Phase 2 for treating complicated urinary tract infections and pyelonephritis.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 16, 2024

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    08

    NRx Pharmaceuticals

    U.S.A
    arrow
    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRx Pharmaceuticals Announces FDA QIDP and Fast Track Designation for NRX-101

    Details : NRX-101 combines D-cycloserine and lurasidone, currently in Phase 2 for treating complicated urinary tract infections and pyelonephritis.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 16, 2024

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    NRx Pharmaceuticals Announces FDA Clearance of its Investigational New Drug (IND) Application for NRX-101 in the Treatment of Complicated Urinary Tract ...

    Details:

    NRX-101 is an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor. It is being evaluated for the treatment of complicated Urinary Tract Infections.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: IND EnablingProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 18, 2023

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    09

    NRx Pharmaceuticals

    U.S.A
    arrow
    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : IND Enabling

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRx Pharmaceuticals Announces FDA Clearance of its Investigational New Drug (IND) Application for ...

    Details : NRX-101 is an oral, fixed-dose combination of D-cycloserine and lurasidone, targets the brain's N-methyl-D-aspartate (NMDA) receptor. It is being evaluated for the treatment of complicated Urinary Tract Infections.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 18, 2023

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    NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis

    Details:

    D-Cycloserine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Tract Infections.


    Lead Product(s): Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Amino Acid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 13, 2023

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    10

    NRx Pharmaceuticals

    U.S.A
    arrow
    BOS Manchester
    Not Confirmed

    NRx Pharmaceuticals

    U.S.A
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    BOS Manchester
    Not Confirmed
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    Lead Product(s) : Cycloserine,Lurasidone Hydrochloride

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis

    Details : D-Cycloserine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Tract Infections.

    Product Name : Undisclosed

    Product Type : Amino Acid

    Upfront Cash : Inapplicable

    November 13, 2023

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    01

    Dr. Reddy's Laboratories

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

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    Flag India
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    Regulatory Info : RX

    Registration Country : USA

    LURASIDONE HYDROCHLORIDE

    Brand Name : LURASIDONE HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2021-08-24

    Application Number : 208047

    Regulatory Info : RX

    Registration Country : USA

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    Dr. Reddy's Laboratories

    India
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    Booth #RH.E02
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Regulatory Info : RX

    Registration Country : USA

    LURASIDONE HYDROCHLORIDE

    Brand Name : LURASIDONE HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 40MG

    Packaging :

    Approval Date : 2021-08-24

    Application Number : 208047

    Regulatory Info : RX

    Registration Country : USA

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    Dr. Reddy's Laboratories

    India
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    Booth #RH.E02
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
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    Regulatory Info : RX

    Registration Country : USA

    LURASIDONE HYDROCHLORIDE

    Brand Name : LURASIDONE HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 60MG

    Packaging :

    Approval Date : 2021-08-24

    Application Number : 208047

    Regulatory Info : RX

    Registration Country : USA

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    04

    Dr. Reddy's Laboratories

    India
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    CPhI India
    Booth #RH.E02
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    LURASIDONE HYDROCHLORIDE

    Brand Name : LURASIDONE HYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 80MG

    Packaging :

    Approval Date : 2021-08-24

    Application Number : 208047

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    05

    Polpharma

    Poland
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    CPhI India
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    Virtual BoothEuropean CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Lurasidonhydroklorid

    Brand Name : Polur

    Dosage Form : Film Coated Tablet

    Dosage Strength : 18.5mg

    Packaging :

    Approval Date : 14/05/2025

    Application Number : 20240923000013

    Regulatory Info : Approved

    Registration Country : Sweden

    Polpharma CB

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    06

    Polpharma

    Poland
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    Virtual BoothEuropean CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Lurasidonhydroklorid

    Brand Name : Polur

    Dosage Form : Film Coated Tablet

    Dosage Strength : 37mg

    Packaging :

    Approval Date : 14/05/2025

    Application Number : 20240923000020

    Regulatory Info : Approved

    Registration Country : Sweden

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    07

    Polpharma

    Poland
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    Virtual BoothEuropean CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Regulatory Info : Approved

    Registration Country : Sweden

    Lurasidonhydroklorid

    Brand Name : Polur

    Dosage Form : Film Coated Tablet

    Dosage Strength : 74mg

    Packaging :

    Approval Date : 14/05/2025

    Application Number : 20240923000037

    Regulatory Info : Approved

    Registration Country : Sweden

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    08

    Sunovion Pharmaceuticals

    U.S.A
    CPhI India
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    Sunovion Pharmaceuticals

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    LURASIDONE HYDROCHLORIDE

    Brand Name : LATUDA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 40MG

    Packaging :

    Approval Date : 2010-10-28

    Application Number : 200603

    Regulatory Info : RX

    Registration Country : USA

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    09

    Sunovion Pharmaceuticals

    U.S.A
    CPhI India
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    Sunovion Pharmaceuticals

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    LURASIDONE HYDROCHLORIDE

    Brand Name : LATUDA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 80MG

    Packaging :

    Approval Date : 2010-10-28

    Application Number : 200603

    Regulatory Info : RX

    Registration Country : USA

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    Sunovion Pharmaceuticals

    U.S.A
    CPhI India
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    LURASIDONE HYDROCHLORIDE

    Brand Name : LATUDA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2011-12-07

    Application Number : 200603

    Regulatory Info : RX

    Registration Country : USA

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    Australia

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    Alphapharm Pty Ltd

    Australia
    BOS Manchester
    Not Confirmed
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    Alphapharm Pty Ltd

    Australia
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    BOS Manchester
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    Lurasidone

    Brand Name : Lavione

    Dosage Form : tablet

    Dosage Strength : 40 mg

    Packaging : 30

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    Registration Country : Australia

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    Alphapharm Pty Ltd

    Australia
    BOS Manchester
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    Alphapharm Pty Ltd

    Australia
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    BOS Manchester
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    Lurasidone

    Brand Name : Lavione

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    Apotex Pty Ltd

    Canada
    BOS Manchester
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    Apotex Pty Ltd

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    BOS Manchester
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    Lurasidone

    Brand Name : APO-Lurasidone

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    Generic Health Pty Ltd

    Australia
    BOS Manchester
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    Generic Health Pty Ltd

    Australia
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    Lurasidone

    Brand Name : Lurasidone Lupin

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    Generic Health Pty Ltd

    Australia
    BOS Manchester
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    Generic Health Pty Ltd

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    BOS Manchester
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    Lurasidone

    Brand Name : Lurasidone Lupin

    Dosage Form : tablet

    Dosage Strength : 80 mg

    Packaging : 30

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    ABOUT THIS PAGE

    Looking for 367514-88-3 / Lurasidone Hydrochloride API manufacturers, exporters & distributors?

    Lurasidone Hydrochloride manufacturers, exporters & distributors 1

    19

    PharmaCompass offers a list of Lurasidone Hydrochloride 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 Lurasidone Hydrochloride manufacturer or Lurasidone Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Lurasidone Hydrochloride

    Synonyms

    Lurasidone hcl, 367514-88-3, Latuda, Sm-13496, Lurasidone hydrochloride [usan], Sm 13496

    Cas Number

    367514-88-3

    Unique Ingredient Identifier (UNII)

    O0P4I5851I

    About Lurasidone Hydrochloride

    A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic 2A and 2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.

    Lurasidone HCl Manufacturers

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

    Lurasidone HCl Suppliers

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

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

    Lurasidone HCl USDMF

    A Lurasidone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurasidone HCl active pharmaceutical ingredient (API) in detail. Different forms of Lurasidone HCl DMFs exist exist since differing nations have different regulations, such as Lurasidone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Lurasidone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Lurasidone HCl USDMF includes data on Lurasidone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurasidone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Lurasidone HCl suppliers with USDMF on PharmaCompass.

    Lurasidone HCl JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Lurasidone HCl Drug Master File in Japan (Lurasidone HCl JDMF) empowers Lurasidone HCl API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Lurasidone HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Lurasidone HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Lurasidone HCl suppliers with JDMF on PharmaCompass.

    Lurasidone HCl KDMF

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

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

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

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

    Lurasidone HCl WC

    A Lurasidone HCl written confirmation (Lurasidone HCl WC) is an official document issued by a regulatory agency to a Lurasidone HCl manufacturer, verifying that the manufacturing facility of a Lurasidone HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lurasidone HCl APIs or Lurasidone HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Lurasidone HCl WC (written confirmation) as part of the regulatory process.

    click here to find a list of Lurasidone HCl suppliers with Written Confirmation (WC) on PharmaCompass.

    Lurasidone HCl 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 Lurasidone HCl as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Lurasidone HCl GMP

    Lurasidone HCl 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 Lurasidone HCl 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 Lurasidone HCl GMP manufacturer or Lurasidone HCl GMP API supplier for your needs.

    Lurasidone HCl CoA

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

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

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