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pilocarpine

Trade name: ocusert

Small moleculeapproved

Approved

Jul 29, 1974

Pilocarpine is an alkaloid extracted from plants of the genus Pilocarpus. The drug stimulates the muscarinic receptors (especially M3, which is expressed in smooth muscles and glands) and thus induces salivation, hypertension and water intake. Pilocarpine was appoved by FDA for the alleviation of symptoms of xerostomia in patients who have undergone radiation therapy to their head and neck cancer and in patients with Sjogren's Syndrome. Ophthalmic solution of the drug is prescribed for the treatment of glaucoma, ocular hypertension, postoperative elevated intraocular pressure, etc. — NCATS

Clinical trial activity

64 trials · 80 clinical orgs · 18 marketing orgs

Phase 1
11
Phase 2
28
Phase 3
19
Phase 4
8

Earliest trial started Aug 1, 1978 (NCT00803803)

Timeline

1970s

  1. Jul 29, 1974

    Alza — Earliest FDA Approval

  2. Jul 29, 1974

    Alza — NDA Organization

  3. Jul 29, 1974

    Akorn, Inc. — NDA Secondary Org

1980s

  1. Oct 1, 1984

    Alcon — NDA Secondary Org

  2. Oct 1, 1984

    Nestle — NDA Secondary Org

1990s

  1. Mar 22, 1994

    Eisai — NDA Secondary Org

  2. Mar 22, 1994

    Advanz Pharma — Marketing Organization

  3. Mar 22, 1994

    Advanz Pharma — NDA Secondary Org

  4. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Nov 16, 2004

    Perrigo — Marketing Organization

  2. Nov 16, 2004

    Padagis Us — Marketing Organization

  3. Dec 22, 2004

    Mylan — Marketing Organization

  4. Dec 22, 2004

    Innogenix — Marketing Organization

  5. Dec 22, 2004

    Amici — Marketing Organization

  6. Oct 14, 2005

    Lannett Company, Inc. — Marketing Organization

  7. Mar 31, 2006

    Impax Laboratories — Marketing Organization

  8. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  9. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jun 22, 2010

    Novartis — NDA Secondary Org

  2. Jun 22, 2010

    Novartis — Marketing Organization

  3. Sep 27, 2017

    Akorn, Inc. — Marketing Organization

  4. Aug 13, 2019

    Aurobindo Pharma — Marketing Organization

  5. Nov 25, 2019

    Somerset Pharmaceuticals — Marketing Organization

2020s

  1. Sep 21, 2020

    Amneal Pharmaceuticals — Marketing Organization

  2. Oct 28, 2021

    AbbVie — Marketing Organization

  3. Oct 28, 2021

    AbbVie — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewJul 29, 1974

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H]1[C@@H](CC2=CN=CN2C)COC1=O
Mol. weight
208.2569 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Sources

Also known as

  • (3s,4r)-3-ethyldihydro-4-((1-methyl-1h-imidazol-5-yl)methyl)-2(3h)-furanone
  • (3s,4r)-3-ethyldihydro-4-((1-methyl-1h-imidazol-5-yl)methyl)-2(3h)-furanone
  • (3s-cis)-3-ethyldihydro-4-[(1-methyl-1h-imidazol-5-yl)methyl]-2(3h)-furanone
  • (3s-cis)-3-ethyldihydro-4-[(1-methyl-1h-imidazol-5-yl)methyl]-2(3h)-furanone
  • agn-190584
  • ins117548
  • isopto carpine
  • isopto carpine
  • ocucarpine
  • ocusert
  • ocusert
  • ocusert
  • ocusert pilo
  • ocusert pilo
  • pilagan
  • pilagan
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • pilocarpine
  • (+)-pilocarpine
  • pilocarpine hcl
  • pilocarpine hcl
  • pilocarpine hcl
  • pilocarpine hydrochloride
  • pilocarpine hydrochloride
  • pilocarpine hydrochloride
  • pilocarpine hydrochloride
  • pilocarpine nitrate
  • pilocarpine nitrate
  • pilocarpine nitrate
  • pilocarpol
  • piloc hcl
  • piloc nit
  • pilogel
  • pilokarpin
  • pilopine
  • pilopine
  • pilopine hs
  • pilopine hs
  • presbidrops
  • salagen
  • salagen
  • salagen
  • salagen
  • salagen
  • salagen
  • sno pilo
  • sno pilo
  • syncarpine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07113210Phase 4Jul 18, 2025University of Alabama, Birmingham
NCT07012512N/AJun 1, 2025Mansoura University
NCT06783686Early Phase 1 (Phase 1)Jan 30, 2025Novus Vision LLC
NCT06752278N/AOct 1, 2024Al Azhar University
NCT06451666Phase 3Jun 30, 2024Yiling Pharmaceutical Inc.
NCT05506137Phase 3Jan 31, 2023Maastricht University, ZonMw: The Netherlands Organisation for Health Research and Development
NCT05646719Phase 3Dec 12, 2022Ocuphire Pharma, Inc.
NCT05624320Phase 4Dec 1, 2022AbbVie, Gordon Schanzlin New Vision
NCT05564832Early Phase 1 (Phase 1)Aug 1, 2022Shahid Beheshti University of Medical Sciences
NCT05578001Phase 3Jul 1, 2022Isfahan University
NCT05393089Phase 2Jun 9, 2022Allergan
NCT05308407N/AMay 4, 2022University of Texas at Houston
NCT05352854N/AMay 1, 2022Wenzhou Medical University
NCT05238233Phase 4Apr 1, 2022Prisma Health
NCT05124275Phase 2Dec 31, 2021Glaukos Corporation
NCT05119920Phase 2Dec 31, 2021Glaukos Corporation
NCT05114486Phase 3Nov 3, 2021Eyenovia Inc.
NCT04983589Phase 3Sep 2, 2021Allergan
NCT05006911Phase 1Aug 14, 2021Optall Vision
NCT05001243Phase 1Aug 10, 2021Optall Vision
Showing 20 of 64 trials
Page 1 / 4

Organizations

Research & Development (80)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit9922014
CEDRA Clinical ResearchFor profit4012003
Roxane LaboratoriesFor profit4412003
National Cancer Institute (NCI)Government3111998
AstellasFor profit2212015
Eyenovia Inc.For profit2212020
Glaukos CorporationFor profit2212021
Maastricht UniversityAcademic/Hospital2222019
Ocuphire Pharma, Inc.For profit2222021
Optall VisionFor profit2212021
Orasis Pharmaceuticals Ltd.For profit2212016
Radiation Therapy Oncology GroupAcademic/Hospital2211998
Sungkyunkwan UniversityAcademic/Hospital2122006
Technion UniversityAcademic/Hospital2012016
Wenzhou Medical UniversityAcademic/Hospital2112015
Yeshiva UniversityAcademic/Hospital2212019
AbbVieFor profit1012022
Al Azhar UniversityAcademic/Hospital1112024
AlconFor profit1112007
Canadian Cancer Trials GroupAcademic/Hospital1111998
80 organizations
Page 1 / 4

Marketing (23)

OrganizationOrg typeRelationshipDate
AbbVieFor profitSYNOct 28, 2021
AbbVieFor profitMKTGOct 28, 2021
AbbVieFor profitNDA2Oct 28, 2021
Advanz PharmaFor profitMKTGMar 22, 1994
Advanz PharmaFor profitNDA2Mar 22, 1994
Akorn, Inc.For profitNDA2Jul 29, 1974
Akorn, Inc.For profitMKTGSep 27, 2017
AlconFor profitNDA2Oct 1, 1984
AlzaFor profitNDAJul 29, 1974
AmiciFor profitMKTGDec 22, 2004
Amneal PharmaceuticalsFor profitMKTGSep 21, 2020
Aurobindo PharmaFor profitMKTGAug 13, 2019
EisaiFor profitNDA2Mar 22, 1994
Impax LaboratoriesFor profitMKTGMar 31, 2006
InnogenixFor profitMKTGDec 22, 2004
Lannett Company, Inc.For profitMKTGOct 14, 2005
MylanFor profitMKTGDec 22, 2004
NestleFor profitNDA2Oct 1, 1984
NovartisFor profitNDA2Jun 22, 2010
NovartisFor profitMKTGJun 22, 2010
Padagis UsFor profitMKTGNov 16, 2004
PerrigoFor profitMKTGNov 16, 2004
Somerset PharmaceuticalsFor profitMKTGNov 25, 2019