X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
JS001 (toripalimab) is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions. It is approved in combination with axitinib for the treatment of renal carcinoma.
Lead Product(s): Toripalimab,Axitinib
Therapeutic Area: Oncology Product Name: Tuoyi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2024
Details:
The company intends to use the net proceeds from the private placement to accelerate the clinical development of Axpali (axitinib) for the treatment of wet age-related macular degeneration.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: Axpaxli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Venrock Healthcare Capital Partners
Deal Size: $325.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement February 22, 2024
Details:
Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. It is being developed for the treatment of wet age-related macular degeneration.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: Axpaxli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2024
Details:
Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated in phase 3 trials for the treatment of wet AMD & other retinal diseases.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: Axpaxli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2024
Details:
The company intends to use the proceeds to fund the Phase 3 clinical development of Axpaxli (axitinib intravitreal implant) for the treatment of wet age-related macular degeneration, including its ongoing Phase 3 clinical trial and its planned second Phase 3 clinical trial.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: Axpaxli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $115.1 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 18, 2023
Details:
CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma. It is under Phase 2b clinical trial for the treatment of wet AMD.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
Details:
The Company intends to use the proceeds to fund the Phase 3 clinical development of Axpaxli (axitinib intravitreal implant) for the treatment of wet age-related macular degeneration, including its ongoing Phase 3 clinical trial and its planned second Phase 3 clinical trial.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: Axpaxli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $100.1 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 13, 2023
Details:
AIV001 (axitinib) is a novel intradermally administered product designed for local, prolonged treatment effect for dermatological conditions. Now it has completed phase 1/2 clinical trials for the treatment of patients with nonmelanoma skin cancer.
Lead Product(s): Axitinib
Therapeutic Area: Oncology Product Name: AIV001
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2023
Details:
Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD & other retinal diseases.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: Axpaxli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2023
Details:
OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: OTX-TKI
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2023
Details:
CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently investigate for neovascular age-related macular degeneration.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2023
Details:
JS004/TAB004 (tifcemalimab) is the world’s first-in-human recombinant humanized anti-BTLA (B- and T-lymphocyte attenuator) monoclonal antibody and in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma.
Lead Product(s): Tifcemalimab,Axitinib
Therapeutic Area: Oncology Product Name: JS004
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2023
Details:
OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: OTX-TKI
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2023
Details:
OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of diabetic retinopathy, wet AMD and other retinal disease.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: OTX-TKI
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2023
Details:
CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently investigate for neovascular age-related macular degeneration.
Lead Product(s): Axitinib,Aflibercept
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2023
Details:
Tuoyi (toripalimab) is an anti-PD-1 monoclonal antibody which promotes immune system’s ability to attack and kill tumor cells by blocking PD-1 interactions with its ligands and for enhanced receptor endocytosis function. It is being studied for advanced renal cell carcinoma.
Lead Product(s): Toripalimab,Axitinib
Therapeutic Area: Oncology Product Name: Tuoyi
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2023
Details:
CLS-AX (axitinib) is a tyrosine kinase inhibitor currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. It is being investigated for the treatment if wet AMD.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Details:
OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: OTX-TKI
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2023
Details:
CLS-AX (axitinib) is a tyrosine kinase inhibitor currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. It is being developed for retinal diseases.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2023
Details:
CLS-AX (axitinib) is a tyrosine kinase inhibitor approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. It is being developed as a long-acting therapy for retinal diseases.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2023
Details:
Axitinib Tablets, 1 mg and 5 mg, the generic version of their Inlyta®1 Tablets, 1 mg and 5 mg. Glenmark had previously announced it received tentative approval by the United States Food & Drug Administration for their generic Axitinib Tablets, 1 mg and 5 mg.
Lead Product(s): Axitinib
Therapeutic Area: Oncology Product Name: Axitinib-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 22, 2022
Details:
CLS-AX (axitinib injectable suspension) is proprietary suspension of axitinib tyrosine kinase inhibitor for suprachoroidal injection approved to treat renal cell cancer that achieves pan-VEGF blockade, inhibit VEGF receptors-1, -2, and -3 with high potency and specificity.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2022
Details:
Clearside intends to use the proceeds from the agreement to support ongoing clinical development of its pipeline, including CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector®.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: HealthCare Royalty Partners
Deal Size: $65.0 million Upfront Cash: $32.5 million
Deal Type: Agreement August 08, 2022
Details:
CLS-AX (axitinib) is proprietary suspension of axitinib for suprachoroidal injection, a tyrosine kinase inhibitor approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2022
Details:
Based on early data from our Australian Phase 1 clinical trial, OTX-TKI has initially demonstrated acceptable tolerability, preliminary biological activity in some patients and durability for up to six months or longer in some cases
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: OTX-TKI
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2021
Details:
Glenmark has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta Tablets, 1 mg and 5 mg, of PF Prism C.V.
Lead Product(s): Axitinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
Company will present two posters and a paper at this year’s American Academy of Ophthalmology (AAO) that continue to highlight Ocular Therapeutix’s differentiated ophthalmology programs, including real world data on DEXTENZA® and new clinical data in OTX-TKI.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: OTX-TKI
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2020
Details:
Phase 1/2a trial in wet AMD patients is expected to be an open-label, dose-escalation study to assess the safety and tolerability of single doses of CLS-AX administered through suprachoroidal injection after two or more prior treatments with an intravitreal anti-VEGF agent.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2020
Details:
Bavencio is an immune checkpoint inhibitor targeting PD-L18 and axitinib is an antiangiogenic VEGF-targeted TKI, their complementary mechanisms of action targeting two key pathways that tumours use to grow.
Lead Product(s): Avelumab,Axitinib
Therapeutic Area: Oncology Product Name: Bavencio
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2020
Details:
Multiple posters and oral presentations on Clearside’s pipeline and its proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) were delivered at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: CLS-AX
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma.
Lead Product(s): Toripalimab,Axitinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Details:
Suprachoroidal injection platform featured in multiple indications including wet AMD, uveitis, diabetic macular edema, and ocular gene therapy.
Lead Product(s): Axitinib
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2020
Details:
Nektar and Bristol-Myers Squibb will expand the active clinical development program for bempeg plus nivolumab from three ongoing registrational trials.
Lead Product(s): Bempegaldesleukin,Nivolumab,Axitinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Bristol Myers Squibb
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 10, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
