apraclonidine

Trade name: iopidine

Small moleculeapproved

Approved

Dec 31, 1987

Apraclonidine (IOPIDINE) is an α2-adrenergic receptor agonist and a weak α1-adrenergic receptor agonist. It is used for the prevention and treatment of postsurgical intraocular pressure elevation. The following adverse events, occurring in less than 2% of patients, were reported in association with the use of IOPIDINE Ophthalmic Solution in laser surgery: ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, and mydriasis. Interactions with other agents have not been investigated. — NCATS

Clinical trial activity

5 trials · 4 clinical orgs · 4 marketing orgs

Phase 1
0
Phase 2
3
Phase 3
2
Phase 4
1

Earliest trial started Aug 1, 2006 (NCT00567411)

Timeline

1980s

  1. Dec 31, 1987

    Novartis — Earliest FDA Approval

  2. Dec 31, 1987

    Novartis — NDA Organization

  3. Dec 31, 1987

    Novartis — NDA Secondary Org

  4. Dec 31, 1987

    Novartis — Marketing Organization

  5. Dec 31, 1987

    Harrow Health — Marketing Organization

  6. Dec 31, 1987

    Harrow Health — NDA Secondary Org

2000s

  1. Mar 12, 2009

    Akorn, Inc. — Marketing Organization

  2. Mar 12, 2009

    Rising Pharmaceuticals — Marketing Organization

2020s

  1. Jan 1, 2020

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2024

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedDec 31, 1987

Chemistry & pharmacology

Loading structure…

SMILES

Nc1cc(Cl)c(N=C2NCCN2)c(Cl)c1
Mol. weight
245.11 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 2-(4-amino-2,6-dichloro)phenyliminoimidazolidine
  • 4-aminoclonidine
  • 4-aminoclonidine
  • 4-aminoclonidine
  • al-02145
  • al-02145
  • alo 2145
  • alo-2145
  • aminoclonidine monohydrochloride
  • aplonidine
  • aplonidine hcl
  • aplonidine hcl
  • apraclonidina
  • apraclonidina
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine
  • apraclonidine hcl
  • apraclonidine hcl
  • apraclonidine hcl
  • apraclonidine hydrochloride
  • apraclonidine hydrochloride
  • apraclonidine hydrochloride
  • apraclonidine hydrochloride
  • apraclonidine hydrochloride
  • apraclonidinum
  • apraclonidinum
  • iopidine
  • iopidine
  • iopidine
  • iopidine
  • iopidine 1%
  • iopimax
  • lopidine
  • p-aminoclonidine
  • para-aminoclonidine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06538662Phase 3Oct 7, 2024Alcon
NCT06444529Phase 3Aug 21, 2024Alcon
NCT05167760Phase 4Feb 28, 2023University of Alabama, Birmingham
NCT05045248Phase 2Jun 1, 2020American University of Beirut
NCT00567411N/AAug 1, 2006United States Army
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AlconFor profit2212024
American University of BeirutAcademic/Hospital1112020
United States ArmyGovernment1112006
University of Alabama, BirminghamAcademic/Hospital1112023
4 organizations
Page 1 / 1

Marketing (8)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGMar 12, 2009
Akorn, Inc.For profitSYNMar 12, 2009
Harrow HealthFor profitMKTGDec 31, 1987
Harrow HealthFor profitNDA2Dec 31, 1987
NovartisFor profitNDADec 31, 1987
NovartisFor profitNDA2Dec 31, 1987
NovartisFor profitMKTGDec 31, 1987
Rising PharmaceuticalsFor profitMKTGMar 12, 2009