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TRS01 (dazdotuftide) is a first-in-class NF-κB signaling pathway inhibitor, which is under phase 3 clinical development for the treatment of non-infectious uveitis including uveitic glaucoma.
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
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 16, 2024
Details:
TRS01 (dazdotuftide) is a bio-inspired novel proprietary technology platform, based on a New Chemical Entity (NCE) with a disruptive mechanism of action that modulate macrophages from inflammatory macrophages (M1) to IL-10 secreting ant-inflammatory macrophages (M2).
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
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 13, 2023
Details:
TRS01 (dazdotuftide) is a bio-inspired novel proprietary technology platform, based on a New Chemical Entity (NCE) with a disruptive mechanism of action that modulate macrophages from inflammatory macrophages (M1) to IL-10 secreting ant-inflammatory macrophages (M2).
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
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 August 23, 2023
Details:
TRS01 is a potent fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma – that is considered an end-stage condition of uveitis.
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
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 August 08, 2022
Details:
TRS01 is a potent fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma.
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
Highest Development Status: Phase IIIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2021
Details:
Following a successful End of Phase II meeting with the FDA, the Company obtained all necessary regulatory approvals to execute phase 3 for TRS01 and has recruited leading uveitis experts as principal investigators.
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
Highest Development Status: Phase I/ Phase IIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing August 24, 2021
Details:
In the Pre-IND meeting, Tarsier Pharma received FDA's guidance regarding the CMC requirements for slow-release formulation of TRS02. Clarity regarding bridging nonclinical studies requirements and clinical strategy were also obtained.
Lead Product(s): TRS02
Therapeutic Area: Ophthalmology Product Name: TRS02
Highest Development Status: IND EnablingProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
Company received important feedback on its trial design and program for its TRS01 Phase 3 program in uveitis, including feedback on its nonclinical and CMC plans supporting submission of a New Drug Application (NDA) in the U.S.
Lead Product(s): TRS01,Adapalene
Therapeutic Area: Ophthalmology Product Name: TRS01
Highest Development Status: Phase IIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2020
Details:
Results showed a statistically significant improvement in the signs and symptoms of the disease, with the TRS01 high-dose usage being superior to low-dose in a few important measures.
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
Highest Development Status: Phase I/ Phase IIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
TRS01 is a Potential topical immune-modulator agent with a novel mechanism of action for treatment of ocular inflammation. This phase I/II trial is a dose ranging trial to evaluate the safety and efficacy of TRS01 in patients with anterior non-infectious active uveitis.
Lead Product(s): TRS01
Therapeutic Area: Ophthalmology Product Name: TRS01
Highest Development Status: Phase I/ Phase IIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
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