Drugs / Reproxalap

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Rejected (CRL) US (FDA) — dry eye syndrome 2026-03-17

“receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap” aldeyra.com ↗

Filed US (FDA) — dry eye syndrome 2025-06-17

“today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap” aldeyra.com ↗

Rejected (CRL) US (FDA) — dry eye syndrome 2025-04-03

“receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap” aldeyra.com ↗

Filed US (FDA) — dry eye syndrome 2024-10-03

“today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap” aldeyra.com ↗

Rejected (CRL) US (FDA) — dry eye syndrome 2023-11-27

“receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap” aldeyra.com ↗

Trials 22

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/23 trials
Phase 1/2 NCT06826196 Mar 2025 → Oct 2026 expected alopecia areata Aldena Therapeutics Recruiting No outcome recorded
Phase 1/2 NCT03709121 Oct 2018 → Mar 2019 atopic conjunctivitis Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 1/2 NCT03660878 Sep 2018 → Nov 2019 conjunctivitis Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 28 trials
Phase 2 NCT05424549 Mar → May 2022 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT05102409 Sep → Oct 2021 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT04971031 Jun → Sep 2021 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03916042 Apr → Nov 2019 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03404115 Jan → Jul 2018 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03162783 May → Jul 2017 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03012165 Dec 2016 → May 2017 conjunctivitis Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT02406209 Mar 2015 → Apr 2016 non-infectious anterior uveitis Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 2/31 trial · 1 missed
Phase 2/3 NCT04674358 Nov 2020 → Sep 2021 dry eye syndrome Aldeyra Therapeutics, Inc. Completed Missed primary
Phase 310 trials · 3 met primary · 1 missed
Phase 3 NCT06493604 Jun 2024 → Feb 2025 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT06424444 Apr → Nov 2024 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT06389214 Apr → Jun 2024 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT05234554 Jan 2022 → Apr 2023 conjunctivitis Aldeyra Therapeutics, Inc. Completed Met primary
Phase 3 NCT05062330 Aug 2021 → Mar 2022 dry eye syndrome Aldeyra Therapeutics, Inc. Completed Met primary
Phase 3 NCT04735393 Jan 2021 → Oct 2022 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT03879863 Apr → Oct 2019 dry eye syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT03445650 Jul 2018 → Jan 2020 Sjogren-Larsson syndrome Aldeyra Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT03494504 Mar → Nov 2018 conjunctivitis Aldeyra Therapeutics, Inc. Completed Met primary
Phase 3 NCT03131154 Apr 2017 → Apr 2019 non-infectious anterior uveitis Aldeyra Therapeutics, Inc. Completed Missed primary
Comparator or background therapy1 trial
Phase 3 NCT04207736 Comparator Dec 2019 → Feb 2021 eye allergy Aldeyra Therapeutics, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 43

DateIssuerRelease
2026-03-17 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease aldeyra.com ↗
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.
2025-12-15 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease aldeyra.com ↗
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease.
2025-07-17 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease aldeyra.com ↗
2025-06-17 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease aldeyra.com ↗
today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap
2025-05-05 Aldeyra Therapeutics, Inc. Results Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Chamber Trial of Reproxalap and Plans NDA Resubmission aldeyra.com ↗
In a Dry Eye Chamber Trial, Reproxalap Was Statistically Superior (P=0.002) to Vehicle in Primary Endpoint of Ocular Discomfort
2025-04-03 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease aldeyra.com ↗
2024-11-18 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease, Expands AbbVie Option Agreement aldeyra.com ↗
2024-10-03 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease aldeyra.com ↗
today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.
2024-08-08 Aldeyra Therapeutics, Inc. Results Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Clinical Trial of Reproxalap aldeyra.com ↗
Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), a U.S. Food and Drug Administration (FDA)-accepted symptom of dry eye disease.
2023-11-27 Aldeyra Therapeutics, Inc. Regulatory Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease aldeyra.com ↗
the FDA stated in the letter that the NDA did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes”
2023-06-15 Aldeyra Therapeutics, Inc. Results Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis aldeyra.com ↗
The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.
2023-02-28 Aldeyra Therapeutics, Inc. Results Aldeyra Therapeutics Announces Positive Top-Line Results from 12-Month Safety Clinical Trial of Reproxalap in Patients with Dry Eye Disease aldeyra.com ↗
The primary endpoints of treatment-related serious adverse events in ocular safety were not observed in any patient.

All press releases naming this drug 57 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

FieldValueCited text
Known as reproxalap “This clinical trial assessed the activity of reproxalap, a novel reactive aldehyde species modulator, and estimated clinically relevant thresholds for changes in ocular itching...” PMID 35585427 ↗ May 2022
20

“Randomized Phase 2 Trial of Reproxalap, a Novel Reactive Aldehyde Species Inhibitor, in Patients with Noninfectious Anterior Uveitis: Model for Corticosteroid Replacement.” PMID 32955967 ↗ Sep 2020

“The results suggest that the novel RASP inhibitor reproxalap has the potential to mitigate the signs and symptoms of DED” PMID 33450164 ↗ Jan 2021

NCT05062330 ↗

NCT03709121 ↗

NCT04207736 ↗

NCT03494504 ↗

NCT06389214 ↗

NCT05102409 ↗

NCT03445650 ↗

NCT03404115 ↗

Show 10 more sources

Known as ADX-102 “ADX-102 1% Topical Dermal Cream (reproxalap)” NCT03445650 ↗
2

NCT03012165 ↗

NCT03131154 ↗

Known as ALD-102 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06826196 ↗
Action Inhibit “reproxalap, a novel inhibitor of reactive aldehyde species (RASP), for the treatment of ocular inflammation” PMID 32955967 ↗ Sep 2020
Modality Other / unclassified “Reproxalap, a novel reactive aldehyde species modulator” PMID 35585427 ↗ May 2022
Route Topical “reproxalap 0.5% ophthalmic solution (4 times daily for 6 weeks)” PMID 32955967 ↗ Sep 2020