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1. Ncgc00356590-01
2. Sr-01000942221
3. Sr-01000942221-2
Molecular Weight | 197.841 g/mol |
---|---|
Molecular Formula | As2O3 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 3 |
Rotatable Bond Count | 0 |
Exact Mass | 197.82793 g/mol |
Monoisotopic Mass | 197.82793 g/mol |
Topological Polar Surface Area | 27.7 Ų |
Heavy Atom Count | 5 |
Formal Charge | 0 |
Complexity | 33.4 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-06
Pay. Date : 2014-04-07
DMF Number : 26075
Submission : 2012-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33453
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-12
Pay. Date : 2019-06-14
DMF Number : 33758
Submission : 2019-06-07
Status : Active
Type : II
NDC Package Code : 64757-0001
Start Marketing Date : 2014-11-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-23
Pay. Date : 2017-01-20
DMF Number : 31325
Submission : 2017-01-31
Status : Active
Type : II
NDC Package Code : 72659-245
Start Marketing Date : 2018-01-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20033
Submission : 2006-12-13
Status : Active
Type : II
Registration Number : 224MF10077
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2012-04-08
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27382
Submission : 2013-09-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21092
Submission : 2007-12-03
Status : Inactive
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-06
Pay. Date : 2014-04-07
DMF Number : 26075
Submission : 2012-05-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-12
Pay. Date : 2019-06-14
DMF Number : 33758
Submission : 2019-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33453
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20033
Submission : 2006-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21092
Submission : 2007-12-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2017-01-20
DMF Number : 31325
Submission : 2017-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27382
Submission : 2013-09-23
Status : Inactive
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
About the Company : Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad rang...
About the Company : Heraeus Precious Metals business line Pharmaceutical Ingredients is specialized in the production of generic APIs as well as the exclusive synthesis of cytotoxic compounds from the...
Details:
Arscimed (arsenic trioxide) is a thioredoxin reductase 1 inhibitor small molecule drug candidate, which is being evaluated for the treatment of chronic graft versus host disease.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: Arscimed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2024
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioSenic Releases New Analysis of Phase 2 Data for Arsenic Trioxide in cGvHD
Details : Arscimed (arsenic trioxide) is a thioredoxin reductase 1 inhibitor small molecule drug candidate, which is being evaluated for the treatment of chronic graft versus host disease.
Brand Name : Arscimed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 18, 2024
Details:
Medsenic and Phebra should facilitate the final steps of manufacturing, clinical confirmation of efficacy and subsequent commercialization of oral ArsciCor (arsenic trioxide) in cGvHD.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: ArsciCor
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Phebra
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 02, 2024
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Phebra
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Medsenic Subsidiary Signs Licensing Agreement with Phebra PTY Ltd
Details : Medsenic and Phebra should facilitate the final steps of manufacturing, clinical confirmation of efficacy and subsequent commercialization of oral ArsciCor (arsenic trioxide) in cGvHD.
Brand Name : ArsciCor
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 02, 2024
Details:
The proceeds of the financing will essentially contribute to continuing to advance the clinical development of Arscimed (arsenic trioxide) in the treatment of chronic graft versus host disease.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: Arscimed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: ABO Securities
Deal Size: $2.2 million Upfront Cash: Undisclosed
Deal Type: Agreement June 21, 2024
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : ABO Securities
Deal Size : $2.2 million
Deal Type : Agreement
BioSenic Signs a New Subscription Agreement for a Maximum of EUR 2.1M in Convertible Bonds
Details : The proceeds of the financing will essentially contribute to continuing to advance the clinical development of Arscimed (arsenic trioxide) in the treatment of chronic graft versus host disease.
Brand Name : Arscimed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 21, 2024
Details:
BioSenic will use proceeds for a Phase 3 trial with Arscimed (oral arsenic trioxide) for first-line treatment of chronic graft-versus-host disease.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: Arscimed
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: Gestys Santé Biotech
Deal Size: $0.5 million Upfront Cash: Undisclosed
Deal Type: Private Placement February 02, 2024
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Gestys Santé Biotech
Deal Size : $0.5 million
Deal Type : Private Placement
BioSenic Raises €500,000 in Private Placement of New Shares with Established New Investors
Details : BioSenic will use proceeds for a Phase 3 trial with Arscimed (oral arsenic trioxide) for first-line treatment of chronic graft-versus-host disease.
Brand Name : Arscimed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 02, 2024
Details:
The agreement aims for the development of the first oral formulation of ArsciCor (arsenic troxide) in the field of several targeted autoimmune diseases, including for cGvHD treatment.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: ArsciCor
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: BioSenic
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 15, 2024
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : BioSenic
Deal Size : Undisclosed
Deal Type : Agreement
BioSenic Reaches Agreement with Phebra on Oral Arsenic Trioxide Development for cGvHD
Details : The agreement aims for the development of the first oral formulation of ArsciCor (arsenic troxide) in the field of several targeted autoimmune diseases, including for cGvHD treatment.
Brand Name : ArsciCor
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 15, 2024
Details:
The proceeds from the financing will contribute to advancing clinical development of BioSenic’s lead asset its ATO product, Arscimed (arsenic trioxide), for treating chronic graft versus host disease.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: Arscimed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: ABO Securities
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing January 08, 2024
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : ABO Securities
Deal Size : Undisclosed
Deal Type : Financing
BioSenic Signs a New Subscription Agreement for a Maximum of EUR 1.2M in Convertible Bonds
Details : The proceeds from the financing will contribute to advancing clinical development of BioSenic’s lead asset its ATO product, Arscimed (arsenic trioxide), for treating chronic graft versus host disease.
Brand Name : Arscimed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 08, 2024
Details:
ATO (arsenic trioxide) is administered daily by IV infusions, which is investigated for the treatment of Graft Versus Host Disease, Systemic Sclerosis, Systemic Lupus Erythematosus and infectious disease.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: OATO
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2023
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ATO (arsenic trioxide) is administered daily by IV infusions, which is investigated for the treatment of Graft Versus Host Disease, Systemic Sclerosis, Systemic Lupus Erythematosus and infectious disease.
Brand Name : OATO
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 27, 2023
Details:
Under the license agreement, Medsenic agreed to commence a clinical study using Phebra's oral formulation OATO (arsenic trioxide) for the treatment of Graft Versus Host Disease, Systemic Sclerosis, Systemic Lupus Erythematosus and infectious diseases.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: OATO
Study Phase: UndisclosedProduct Type: Small molecule
Sponsor: Phebra
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 29, 2023
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Phebra
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Biosenic Provides Update Regarding Current License Agreement With Phebra
Details : Under the license agreement, Medsenic agreed to commence a clinical study using Phebra's oral formulation OATO (arsenic trioxide) for the treatment of Graft Versus Host Disease, Systemic Sclerosis, Systemic Lupus Erythematosus and infectious diseases.
Brand Name : OATO
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 29, 2023
Details:
Arscimed® (arsenic trioxide), is a able to radically modify the autoimmune cascade and normalise the immune system without causing nonspecific immunosuppressionbeing studied for cGvHD.
Lead Product(s): Arsenic Trioxide,Metal ion
Therapeutic Area: Immunology Brand Name: Arscimed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Lead Product(s) : Arsenic Trioxide,Metal ion
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Arscimed® (arsenic trioxide), is a able to radically modify the autoimmune cascade and normalise the immune system without causing nonspecific immunosuppressionbeing studied for cGvHD.
Brand Name : Arscimed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 18, 2023
Details:
The BioSenic autoimmune platform has been constructed to target systemic autoimmune diseases using arsenic trioxide (Arscimed, ATO). This uses ATO’s first-in-class mechanism of action as an active anti-inflammatory and immunomodulatory agent.
Lead Product(s): Arsenic Trioxide
Therapeutic Area: Immunology Brand Name: Arscimed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2022
Lead Product(s) : Arsenic Trioxide
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioSenic SA Provides Update On Its Autoimmune Disease Platform Based On ATO (arsenic trioxide)
Details : The BioSenic autoimmune platform has been constructed to target systemic autoimmune diseases using arsenic trioxide (Arscimed, ATO). This uses ATO’s first-in-class mechanism of action as an active anti-inflammatory and immunomodulatory agent.
Brand Name : Arscimed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 08, 2022
Regulatory Info :
Registration Country : Iran
Brand Name : Trisenal
Dosage Form : Vial
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 1MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ARSENIC TRIOXIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1MG/ML
Packaging :
Approval Date : 2018-11-15
Application Number : 209315
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ARSENIC TRIOXIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG/ML
Packaging :
Approval Date : 2021-08-19
Application Number : 210739
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TRISENOX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG/ML
Packaging :
Approval Date : 2017-10-13
Application Number : 21248
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ARSENIC TRIOXIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2MG/ML
Packaging :
Approval Date : 2021-10-07
Application Number : 215059
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ARSENIC TRIOXIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 1MG/ML
Packaging :
Approval Date : 2019-05-06
Application Number : 209873
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ARSENIC TRIOXIDE FOR INJECTION
Dosage Form : SOLUTION
Dosage Strength : 10MG/10ML
Packaging :
Approval Date :
Application Number : 2513420
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Sweden
Brand Name : TRISENOX
Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION
Dosage Strength : 1 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Trisenox
Dosage Form : Inf Conc
Dosage Strength : 12mg/6ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : TRISENOX
Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION
Dosage Strength : 1 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Trisenox
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 1 mg/ml
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Trisenox
Dosage Form : Inf Conc
Dosage Strength : 12mg/6ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
DRUG PRODUCT COMPOSITIONS
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Global Sales Information
Dosage Form : Concentrate to the infusion flui...
Dosage Strength : 1 mg/ml
Price Per Pack (Euro) : 4,253.05
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Inf Conc
Dosage Strength : 12mg/6ml
Price Per Pack (Euro) : 3416.68
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
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