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    Synopsis

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    Chemistry

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    Also known as: 130209-82-4, Xalatan, Phxa41, Phxa-41, Xa41, Phxa 41
    Molecular Formula
    C26H40O5
    Molecular Weight
    432.6  g/mol
    InChI Key
    GGXICVAJURFBLW-CEYXHVGTSA-N
    FDA UNII
    8S5FB3XXG8
    Latanoprost
    A prostaglandin F analog used to treat OCULAR HYPERTENSION in patients with GLAUCOMA.
    Latanoprost is a Prostaglandin Analog.
    1 2D Structure

    Latanoprost

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate
    2.1.2 InChI
    InChI=1S/C26H40O5/c1-19(2)31-26(30)13-9-4-3-8-12-22-23(25(29)18-24(22)28)17-16-21(27)15-14-20-10-6-5-7-11-20/h3,5-8,10-11,19,21-25,27-29H,4,9,12-18H2,1-2H3/b8-3-/t21-,22+,23+,24-,25+/m0/s1
    2.1.3 InChI Key
    GGXICVAJURFBLW-CEYXHVGTSA-N
    2.1.4 Canonical SMILES
    CC(C)OC(=O)CCCC=CCC1C(CC(C1CCC(CCC2=CC=CC=C2)O)O)O
    2.1.5 Isomeric SMILES
    CC(C)OC(=O)CCC/C=C\C[C@H]1[C@H](C[C@H]([C@@H]1CC[C@H](CCC2=CC=CC=C2)O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    8S5FB3XXG8
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Phxa34

    2. Phxa41

    3. Xalatan

    2.3.2 Depositor-Supplied Synonyms

    1. 130209-82-4

    2. Xalatan

    3. Phxa41

    4. Phxa-41

    5. Xa41

    6. Phxa 41

    7. Xa-41

    8. Latanoprost (isopropyl Ester)

    9. Isopropyl (z)-7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((3r)-3-hydroxy-5-phenylpentyl)cyclopentyl)-5-heptenoate

    10. Propan-2-yl (z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate

    11. Latanoprost, (+/-)-

    12. 6z5b6hvf6o

    13. 8s5fb3xxg8

    14. Latanoprost, Ethanol Solution

    15. Chebi:6384

    16. Propan-2-yl (5z)-7-{(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl}hept-5-enoate

    17. T-2345

    18. T2345

    19. 5-heptenoic Acid, 7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]-, 1-methylethyl Ester, (5z)-

    20. Isopropyl (5z,9alpha,11alpha,15r)-9,11,15-trihydroxy-17-phenyl-18,19,20-trinorprost-5-en-1-oate

    21. Catioprost

    22. (z)-isopropyl 7-((1r,2r,3r,5s)-3,5-dihydroxy-2-((r)-3-hydroxy-5-phenylpentyl)cyclopentyl)hept-5-enoate

    23. 155551-81-8

    24. 5-heptenoic Acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-, 1-methylethyl Ester

    25. Smr000466354

    26. Xalatan (tn)

    27. Unii-6z5b6hvf6o

    28. Latanoprostum

    29. Nova-21027

    30. Latanoprost [usan:inn:ban]

    31. Xa 41

    32. Phxa34 [as 15(r,s)-isomer]

    33. Propan-2-yl (5z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate

    34. Ar-202

    35. Mfcd00216074

    36. Xelpros

    37. L-ppds

    38. Latanoprost [mi]

    39. Latanoprost [inn]

    40. Latanoprost [jan]

    41. Latanoprost [usan]

    42. Unii-8s5fb3xxg8

    43. Latanoprost [vandf]

    44. Chembl1051

    45. Latanoprost [mart.]

    46. Schembl24698

    47. Latanoprost [usp-rs]

    48. Latanoprost [who-dd]

    49. Mls000759468

    50. Mls001424106

    51. Latanoprost (jan/usp/inn)

    52. Gtpl1961

    53. Dtxsid1041057

    54. Latanoprost [orange Book]

    55. Hms2051h11

    56. Hms2089j17

    57. Hms3715n22

    58. Latanoprost [ep Monograph]

    59. Latanoprost [usp Monograph]

    60. Amy30089

    61. Ex-a1770

    62. Hy-b0577

    63. Xalacom Component Latanoprost

    64. Bdbm50240648

    65. S4709

    66. Zinc12468792

    67. Latanoprost, >=98% (hplc), Oil

    68. Rocklatan Component Latanoprost

    69. Akos024458331

    70. Ccg-100946

    71. Db00654

    72. Nc00196

    73. Latanoprost Component Of Rocklatan

    74. Ncgc00246969-01

    75. Ncgc00246969-06

    76. (5z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptanoic Acid 1-methylethyl Ester

    77. As-75099

    78. L0262

    79. D00356

    80. Ab00640005-04

    81. Ab00640005-06

    82. 209l824

    83. A806039

    84. Q634959

    85. Sr-01000759428

    86. J-005764

    87. Sr-01000759428-4

    88. Latanoprost, United States Pharmacopeia (usp) Reference Standard

    89. Tris(2,4-dimethylphenyl)phosphine-5,5',5""""-trisulfonic Acid Trisodium Salt

    90. (1r,2r,3r,5s,3''r)-7-[3,5-dihydroxy-2-(3-hydroxy-5-phenyl-pentyl)-cyclopentyl]-hept-5-enoic Acid Isopropyl Ester

    91. (z)-7-[(1r,2r,3r,5s)-3,5-dihydroxy-2-[(3r)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic Acid Propan-2-yl Ester

    92. 5-heptenoic Acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-, 1-methylethyl Ester, (1r-(1-alpha(z),2-beta(r*),3-alpha,5-alpha))-

    93. 5-heptenoic Acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-1-methylethyl Ester, (1r-(1.alpha.(z),2.beta.(r*),3.alpha.,5.alpha.))-

    94. Isopropyl (5z,9alpha,11alpha,15r)-9,11,15-trihydroxy-17-phenyl-18,19,20-trinor-prost-5-en-1-oate;xalatan

    95. Propan-2-yl (z)-7-[(1r,2r,3r,5s)-3,5-bis(oxidanyl)-2-[(3r)-3-oxidanyl-5-phenyl-pentyl]cyclopentyl]hept-5-enoate

    2.4 Create Date
    2005-12-16
    3 Chemical and Physical Properties
    Molecular Weight 432.6 g/mol
    Molecular Formula C26H40O5
    XLogP34.3
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count14
    Exact Mass432.28757437 g/mol
    Monoisotopic Mass432.28757437 g/mol
    Topological Polar Surface Area87 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity526
    Isotope Atom Count0
    Defined Atom Stereocenter Count5
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameLatanoprost
    PubMed HealthLatanoprost (Into the eye)
    Drug ClassesAntiglaucoma
    Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
    Active IngredientLatanoprost
    Dosage FormSolution/drops; Solution
    RouteOphthalmic; ophthalmic
    Strength0.005%
    Market StatusTentative Approval; Prescription
    CompanyAlcon Res; Par Pharm; Bausch And Lomb; Luitpold; Dr Reddys Labs; Mylan; Akorn

    2 of 4  
    Drug NameXalatan
    PubMed HealthLatanoprost (Into the eye)
    Drug ClassesAntiglaucoma
    Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
    Active IngredientLatanoprost
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength0.005%
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    3 of 4  
    Drug NameLatanoprost
    PubMed HealthLatanoprost (Into the eye)
    Drug ClassesAntiglaucoma
    Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
    Active IngredientLatanoprost
    Dosage FormSolution/drops; Solution
    RouteOphthalmic; ophthalmic
    Strength0.005%
    Market StatusTentative Approval; Prescription
    CompanyAlcon Res; Par Pharm; Bausch And Lomb; Luitpold; Dr Reddys Labs; Mylan; Akorn

    4 of 4  
    Drug NameXalatan
    PubMed HealthLatanoprost (Into the eye)
    Drug ClassesAntiglaucoma
    Drug LabelLatanoprost is a prostaglandin F2 analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C26H40O5 and its chemical structure is:Latanoprost is a...
    Active IngredientLatanoprost
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength0.005%
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    4.2 Drug Indication

    Latanoprost is indicated for the reduction of elevated intraocular pressure in patients who have been diagnosed with open-angle glaucoma or ocular hypertension. Latanoprost may be combined in a product with [Netarsudil], a rho kinase inhibitor, for the same indications. In addition to the above indications, the Canadian monograph for this drug also approves latanoprost for the treatment of elevated intraocular pressure as a result of angle-closure glaucoma that has been treated with peripheral iridotomy or laser iridoplasty.

    FDA Label

    Treatment of glaucoma

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Latanoprost effectively decreases intraocular pressure by increasing uveoscleral outflow. A decrease in intraocular pressure has been measured within 34 hours post-administration, reaches a maximum decrease at 812 hours, and can be maintained for a period of 24 hours. **A note on eye and periorbital changes** Between 3 to 10% of patients taking latanoprost have experienced iris pigmentation after about 3-4 months of latanoprost use. Patients should be notified of this risk before initiating treatment. It may occur in both patients with light-colored irides (green-brown or blue/grey-brown) or dark-colored (brown) irides, but is less pronounced in the latter group. This drug may also cause other ocular effects including infrequent conjunctival hyperemia, pigmentation of periocular tissues, eyelash changes, hypertrichosis, and ocular irritation.

    5.2 MeSH Pharmacological Classification

    Ophthalmic Solutions

    Sterile solutions that are intended for instillation into the eye. It does not include solutions for cleaning eyeglasses or CONTACT LENS SOLUTIONS. (See all compounds classified as Ophthalmic Solutions.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    LATANOPROST
    5.3.2 FDA UNII
    6Z5B6HVF6O
    5.3.3 Pharmacological Classes
    Prostaglandins [CS]; Prostaglandin Analog [EPC]
    5.4 ATC Code

    S01EE01

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    S - Sensory organs

    S01 - Ophthalmologicals

    S01E - Antiglaucoma preparations and miotics

    S01EE - Prostaglandin analogues

    S01EE01 - Latanoprost

    5.5 Absorption, Distribution and Excretion

    Absorption

    This drug is rapidly absorbed in the cornea as an isopropyl ester prodrug and is then activated by the process of hydrolysis. A small amount of this drug is systemically absorbed. The Cmax of latanoprost in the systemic circulation is reached after 5 minutes and is measured to be 53 pg/mL. The Cmax in the aqueous humor is attained within 2 hours after administration. and has been estimated to be 15-30 ng/mL.

    Route of Elimination

    After hepatic beta-oxidation, the metabolites of latanoprost are primarily found to be excreted by the kidneys. About 88% of the latanoprost dose is recovered in the urine after topical administration. About 15% of a dose is reported to be excreted in the feces.

    Volume of Distribution

    The volume of distribution of latanoprost is 0.16 0.02 L/kg. The activated acid form of latanoprost can be measured in aqueous humor in the initial 4 hours post-administration, and it is measured in the plasma only for 1 hour following ophthalmic administration. This drug is more lipophilic than its parent prostaglandin and easily penetrates the cornea. It has been shown to cross the placenta in rats.

    Clearance

    The systemic clearance of latanoprost is 7 mL/min/kg.

    5.6 Metabolism/Metabolites

    After corneal uptake, this prodrug is hydrolyzed and activated by esterases to become a pharmacologically active drug. The small portion of this drug that is able to reach the circulation is found to be metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites through fatty acid beta-oxidation.

    5.7 Biological Half-Life

    The elimination half-life of latanoprost from the plasma is about 17 minutes. The elimination half-life of latanoprost from the eye is estimated at 23 hours.

    5.8 Mechanism of Action

    Elevated intraocular pressure leads to an increased risk of glaucomatous visual field loss. The higher the intraocular pressure, the higher the risk of damage to the optic nerve and loss of visual field. Latanoprost selectively stimulates the prostaglandin F2 alpha receptor and this results in a decreased intraocular pressure (IOP) via the increased outflow of aqueous humor, which is often implicated in cases of elevated intraocular pressure. Possible specific mechanisms of the abovementioned increased aqueous outflow are the remodeling of the extracellular matrix and regulation of matrix metalloproteinases. These actions result in higher tissue permeability related to humor outflow pathways, which likely change outflow resistance and/or outflow rates.

    API Reference Price

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    12-Jan-2021
    09-Dec-2024
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    Drugs in Development

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    Gland Pharma Secures US FDA Approval for Latanoprost Ophthalmic Solution

    Details:

    Xalatan-Generic (latanoprost) is a prostanoid FP receptor agonist, small molecule drug candidate, which is indicated for the treatment of open-angle glaucoma or ocular hypertension


    Lead Product(s): Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: Xalatan-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 02, 2024

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    Lead Product(s) : Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Gland Pharma Secures US FDA Approval for Latanoprost Ophthalmic Solution

    Details : Xalatan-Generic (latanoprost) is a prostanoid FP receptor agonist, small molecule drug candidate, which is indicated for the treatment of open-angle glaucoma or ocular hypertension

    Brand Name : Xalatan-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 02, 2024

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    Akums Drugs inks licensing pact with Canadian firm Triple Hair Inc

    Details:

    Akums gains rights for patented topical formulation, Therapy-07, for the Indian market which combines three medicaments (finasteride,latanoprost,minoxidil) to combat alopecia.


    Lead Product(s): Finasteride,Latanoprost,Minoxidil

    Therapeutic Area: Dermatology Brand Name: Therapy-07

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Akums Drugs & Pharmaceuticals Ltd

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement October 16, 2024

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    Lead Product(s) : Finasteride,Latanoprost,Minoxidil

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Akums Drugs & Pharmaceuticals Ltd

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Akums Drugs inks licensing pact with Canadian firm Triple Hair Inc

    Details : Akums gains rights for patented topical formulation, Therapy-07, for the Indian market which combines three medicaments (finasteride,latanoprost,minoxidil) to combat alopecia.

    Brand Name : Therapy-07

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 16, 2024

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    PolyActiva Wins $1.5M Grant for Ocular Implant in Glaucoma Treatment

    Details:

    The company will use the grant funding to advance the PA5346 (latanoprost) second-generation -releasing ocular implant, which is being evaluated for treatment of Glaucoma.


    Lead Product(s): Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: PA5346

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Medical Research Future Fund

    Deal Size: $1.5 million Upfront Cash: Undisclosed

    Deal Type: Funding May 07, 2024

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    Australia
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    Lead Product(s) : Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Medical Research Future Fund

    Deal Size : $1.5 million

    Deal Type : Funding

    DEALS_DEV arrow-down

    PolyActiva Wins $1.5M Grant for Ocular Implant in Glaucoma Treatment

    Details : The company will use the grant funding to advance the PA5346 (latanoprost) second-generation -releasing ocular implant, which is being evaluated for treatment of Glaucoma.

    Brand Name : PA5346

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    May 07, 2024

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    Qlaris Bio’s Novel IOP-Lowering Product, QLS-111, is Dosed in Phase II Trials

    Details:

    QLS‑111, a first-in-class therapeutic being developed to lower IOP by targeting episcleral venous pressure in combination wth latanoprost for open angle glaucoma and ocular hypertension.


    Lead Product(s): QLS-111,Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: QLS-111

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 02, 2024

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    Lead Product(s) : QLS-111,Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Qlaris Bio’s Novel IOP-Lowering Product, QLS-111, is Dosed in Phase II Trials

    Details : QLS‑111, a first-in-class therapeutic being developed to lower IOP by targeting episcleral venous pressure in combination wth latanoprost for open angle glaucoma and ocular hypertension.

    Brand Name : QLS-111

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 02, 2024

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    Santen Receives European Commission Approval for Catiolanze® (cationic emulsion of latanoprost 50μg/mL) for Lowering of Intraocular Pressure in Open...

    Details:

    Catiolanze® is a preservative-free latanoprost 50μg/mL eye drop cationic emulsion. The active substance latanoprost, a prostaglandin F2α analogue, is a selective proteinoid FP receptor agonist which reduces the IOP by increasing the outflow of aqueous humor.


    Lead Product(s): Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: Catiolanze

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 17, 2023

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    Lead Product(s) : Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Santen Receives European Commission Approval for Catiolanze® (cationic emulsion of latanoprost ...

    Details : Catiolanze® is a preservative-free latanoprost 50μg/mL eye drop cationic emulsion. The active substance latanoprost, a prostaglandin F2α analogue, is a selective proteinoid FP receptor agonist which reduces the IOP by increasing the outflow of aqueous...

    Brand Name : Catiolanze

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 17, 2023

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    PolyActiva Reports Promising Clinical Trial Results For its 6-month Sustained Drug Delivery, Biodegradable Ocular Implant in Glaucoma Patients.

    Details:

    PA5108 Ocular Implant with Prezia™ technology are being developed to offer a safe and effective, fully biodegradable therapy, which is investigated for the treatment of mild to moderate glaucoma.


    Lead Product(s): Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: PA5108

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 02, 2023

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    PolyActiva

    Australia
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    Lead Product(s) : Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    PolyActiva Reports Promising Clinical Trial Results For its 6-month Sustained Drug Delivery, Biode...

    Details : PA5108 Ocular Implant with Prezia™ technology are being developed to offer a safe and effective, fully biodegradable therapy, which is investigated for the treatment of mild to moderate glaucoma.

    Brand Name : PA5108

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 02, 2023

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    Thea Pharma Inc. Launches IYUZEH™ (latanoprost ophthalmic solution) 0.005% in the U.S.

    Details:

    Iyuzeh (latanoprost) is a prostaglandin F2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. It is being indicated for primary open-angle glaucoma (POAG) or ocular hypertension (OHT).


    Lead Product(s): Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: Iyuzeh

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 26, 2023

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    Thea Pharma

    U.S.A
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    Lead Product(s) : Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Thea Pharma Inc. Launches IYUZEH™ (latanoprost ophthalmic solution) 0.005% in the U.S.

    Details : Iyuzeh (latanoprost) is a prostaglandin F2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. It is being indicated for primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

    Brand Name : Iyuzeh

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 26, 2023

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    IYUZEH™ (Latanoprost Ophthalmic Solution) 0.005%, The First and Only Preservative-Free Latanoprost Ophthalmic Solution, Demonstrated Similar IOP Lower...

    Details:

    Iyuzeh (latanoprost) is a prostaglandin F2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. It is being indicated for primary open-angle glaucoma (POAG) or ocular hypertension (OHT).


    Lead Product(s): Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: Iyuzeh

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 03, 2023

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    Thea Pharma

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    Lead Product(s) : Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    IYUZEH™ (Latanoprost Ophthalmic Solution) 0.005%, The First and Only Preservative-Free Latanopro...

    Details : Iyuzeh (latanoprost) is a prostaglandin F2α analogue that is believed to reduce the IOP by increasing the outflow of aqueous humor. It is being indicated for primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

    Brand Name : Iyuzeh

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 03, 2023

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    Alcon Completes Acquisition of Aerie Pharmaceuticals, Inc., Strengthening Company’s Ophthalmic Pharmaceutical Business

    Details:

    Alcon will add Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil ophthalmic solution), as well as AR-15512, a Phase 3 candidate for dry eye disease, and a pipeline of several clinical and preclinical ophthalmic pharmaceutical candidates.


    Lead Product(s): Netarsudil,Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: Rocklatan

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Alcon Inc

    Deal Size: $930.0 million Upfront Cash: Undisclosed

    Deal Type: Acquisition December 22, 2022

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    Alcon Inc

    U.S.A
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    Lead Product(s) : Netarsudil,Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Alcon Inc

    Deal Size : $930.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Alcon Completes Acquisition of Aerie Pharmaceuticals, Inc., Strengthening Company’s Ophthalmic P...

    Details : Alcon will add Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil ophthalmic solution), as well as AR-15512, a Phase 3 candidate for dry eye disease, and a pipeline of several clinical and preclinical ophthalmic pharmace...

    Brand Name : Rocklatan

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    December 22, 2022

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    Thea Pharma Announces FDA Approval of IYUZEH™ for the Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-angle Glaucoma or Ocular ...

    Details:

    IYUZEH™ is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free. IYUZEH™ is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK).


    Lead Product(s): Latanoprost

    Therapeutic Area: Ophthalmology Brand Name: Iyuzeh

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 14, 2022

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    Thea Pharma

    U.S.A
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    Lead Product(s) : Latanoprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Thea Pharma Announces FDA Approval of IYUZEH™ for the Reduction of Elevated Intraocular Pressure...

    Details : IYUZEH™ is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free. IYUZEH™ is formulated without any of the preservatives commonly used in topical ocular preparations, including benzal...

    Brand Name : Iyuzeh

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 14, 2022

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.005%

    USFDA APPLICATION NUMBER - 20597

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    DOSAGE - EMULSION;OPHTHALMIC - 0.005%

    USFDA APPLICATION NUMBER - 206185

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    ABOUT THIS PAGE

    Latanoprost Manufacturers

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

    Latanoprost Suppliers

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

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

    Latanoprost USDMF

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

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

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

    Latanoprost 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 Latanoprost Drug Master File in Japan (Latanoprost JDMF) empowers Latanoprost 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 Latanoprost JDMF during the approval evaluation for pharmaceutical products. At the time of Latanoprost 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 Latanoprost suppliers with JDMF on PharmaCompass.

    Latanoprost KDMF

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

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

    After submitting a Latanoprost 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 Latanoprost API can apply through the Korea Drug Master File (KDMF).

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

    Latanoprost CEP

    A Latanoprost CEP of the European Pharmacopoeia monograph is often referred to as a Latanoprost Certificate of Suitability (COS). The purpose of a Latanoprost CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Latanoprost EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Latanoprost to their clients by showing that a Latanoprost CEP has been issued for it. The manufacturer submits a Latanoprost CEP (COS) as part of the market authorization procedure, and it takes on the role of a Latanoprost CEP holder for the record. Additionally, the data presented in the Latanoprost CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Latanoprost DMF.

    A Latanoprost CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Latanoprost CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Latanoprost suppliers with CEP (COS) on PharmaCompass.

    Latanoprost WC

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

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

    Latanoprost 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 Latanoprost as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Latanoprost GMP

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

    Latanoprost CoA

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

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

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