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Details:
ADX-102 (reproxalap) is an investigational new drug candidate, it is a first-in-class small-molecule modulator of RASP, It is being evaluated for the treatment of dry eye disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX-102
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 March 28, 2024
Details:
ADX-102 (reproxalap) is an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX-102
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 27, 2023
Details:
Under the option agreement, AbbVie has the option to acquire a co-exclusive license to develop, manufacture, and commercialize ADX-102 (reproxalap), a RASP modulator, in the U.S. and an exclusive license to develop, manufacture, and commercialize reproxalap outside the U.S.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: $501.0 million Upfront Cash: $100.0 million
Deal Type: Licensing Agreement November 01, 2023
Details:
ADX-102 (reproxalap), an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX-102
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 June 15, 2023
Details:
ADX-102 (reproxalap), an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX-102
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 April 13, 2023
Details:
ADX-102 (reproxalap), an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX-102
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 28, 2023
Details:
ADX-102 (reproxalap), an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX-102
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 07, 2023
Details:
ADX 102 (Reproxalap), an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 29, 2022
Details:
ADX 102 (reproxalap) is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 October 26, 2022
Details:
ADX 102 (reproxalap), an investigational new drug candidate, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 September 14, 2022
Details:
ADX 102 (Reproxalap) statistically superior to vehicle for both prespecified primary endpoints of Schirmer Test (p=0.0001) and ≥10 mm Schirmer Test responder proportions (p<0.0001).
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 June 08, 2022
Details:
Using computer automated grading of digital photography, the analyses indicated that ADX 102 (reproxalap) demonstrated a statistically significant reduction in ocular redness.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 May 24, 2022
Details:
Post-hoc analysis using computer automated grading indicated that ADX102 (reproxalap) is statistically superior to vehicle (p=0.020) in reducing dry-eye associated ocular redness, the primary endpoint of phase 3 tranquility trial.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 May 18, 2022
Details:
Reproxalap, is a first-in-class small-molecule modulator of RASP, which are elevated in ocular and systemic inflammatory disease, mechanism of action has been supported by demonstration of statistically significant and clinically relevant activity.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 April 21, 2022
Details:
Based on the results of the previously completed Phase 2 and TRANQUILITY clinical trials, TRANQUILITY-2 of 0.25% reproxalap ophthalmic solution, is at least 90% powered to detect a statistically significant difference in Schirmer test or ocular redness endpoints.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 April 05, 2022
Details:
No safety signals were observed in TRANQUILITY, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or serious adverse events. Reproxalap has now been tested in over 1,500 patients.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 December 20, 2021
Details:
Results of the recently completed Phase 2 clinical trial, which enrolled 158 patients and achieved statistical significance in the primary endpoint of ocular redness, ADX 102 is at least 90% powered to detect a statistically significant difference in ocular redness.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 09, 2021
Details:
Reproxalap, a small-molecule immune-modulating covalent inhibitor of RASP, which are elevated in ocular and systemic inflammatory disease. Reproxalap is currently in Phase 3 as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 02, 2021
Details:
Aldeyra anticipates using the net proceeds from the offering for the preparation of a potential New Drug Application submission for Aldeyra’s lead compound, reproxalap; preparations for the commercial launch of reproxalap and the subsequent commercialization of reproxalap.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 28, 2021
Details:
Relative to patients treated with vehicle, patients treated with reproxalap reported statistically significant ocular itching score reduction over all 11 prespecified primary endpoint comparisons from 110 to 210 minutes in the allergen chamber.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: ADX 102
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 April 27, 2021
Details:
The new data presented at AAO this year further support the clinical utility of reproxalap, the first novel mechanistic approach in late-stage allergic conjunctivitis clinical trials in decades, as uniquely effective.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 October 22, 2020
Details:
Compared to vehicle, reproxalap demonstrated statistically significant and clinically relevant improvements in subject-reported ocular itching and tearing and investigator-assessed ocular redness over the duration of exposure in the allergen chamber.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 October 22, 2020
Details:
Based on U.S. FDA meeting minutes, Aldeyra intends to initiate two clinical trials to assess the activity of reproxalap in reducing tear levels of RASP, pro-inflammatory mediators recently accepted by the FDA as an objective sign of dry eye disease.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 July 07, 2020
Details:
In a Phase 2a dry eye disease clinical trial, Aldeyra’s investigational RASP inhibitor reproxalap demonstrated reduction in tear RASP levels following 28 days of treatment.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S FDA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 04, 2020
Details:
The INVIGORATE Trial, which will enroll approximately 120 patients aims to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared with vehicle using an allergen chamber.
Lead Product(s): Reproxalap
Therapeutic Area: Ophthalmology Product Name: Undisclosed
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 21, 2020
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