Drugs / Apraclonidine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) IOPIDINE 1989-12-15 fda.gov
Approved US (FDA) IOPIDINE 1987-12-31 fda.gov

Trials 5 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT05045248 Jun 2020 → Apr 2021 ocular myasthenia gravis American University of Beirut Medical Center Completed No outcome recorded
Phase 33 trials
Phase 3 NCT07531043 Oct 2026 → Feb 2027 expected ocular hyperemia Alcon Research Not yet recruiting No outcome recorded
Phase 3 NCT07578363 Sep 2026 → Mar 2027 expected ocular hyperemia Alcon Research Not yet recruiting No outcome recorded
Phase 3 NCT06444529 Aug → Nov 2024 ocular hyperemia Alcon Research Completed No outcome recorded
Phase 41 trial
Phase 4 NCT05167760 Dec 2025 → Nov 2027 cranial nerve neuropathy, facial paralysis University of Alabama at Birmingham Withdrawn No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
NCT00567411 Comparator Aug 2006 → Jun 2009 ocular hypertension, open-angle glaucoma Walter Reed Army Medical Center Unknown No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Apraclonidine ClinicalTrials.gov intervention name — accepted as the source's own label NCT05167760
5

NCT00567411

NCT06444529

NCT07578363

NCT05045248

NCT07531043

Known as AL-02145 ChEMBL registry synonym — accepted as the source's own label CHEMBL647
Known as Aplonidine hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL647
Known as Apraclonidina ChEMBL registry synonym — accepted as the source's own label CHEMBL647
Known as Apraclonidine Hcl Apraclonidine Hcl 0.5% Oph Soln” NCT05045248
Known as Apraclonidine Hydrochloride “A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness” NCT06444529
Known as Iopidine “Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT” NCT00567411
Action Activate “Apraclonidine elevates the eyelid by activating alpha-2 receptors on Muller's muscle” PMID 37259693 May 2023
Modality Small molecule CHEMBL647
Route Topical “one drop of apraclonidine 0.5% in the fellow eye” NCT00567411