Isopto Carpine

(Pilocarpine)

ApprovedSmall molecule

Pilocarpine is used to treat dry eyes and dry mouth, and can help reduce pressure in the eye for glaucoma patients. It works by stimulating tears and saliva production.[2] Isopto Carpine is currently approved and in use across 12 indications[4].[1]

Isopto Carpine is one of 207 small molecule programs targeting Angle-Closure Glaucoma. It is currently in Approved.

Indications

Total Trials

Active Trials

206

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Angle-Closure GlaucomaActive, not recruiting

MyopiaApproved

MiosisActive, not recruiting

GlaucomaActive, not recruiting

Dry Eye SyndromeApproved

Ocular HypertensionActive, not recruiting

PresbyopiaActive, not recruiting

CataractActive, not recruiting

XerostomiaActive, not recruiting

Open-Angle GlaucomaActive, not recruiting

Angle-Closure GlaucomaApproved

Active, not recruiting

MyopiaApproved

Approved

MiosisApproved

Active, not recruiting

GlaucomaApproved

Active, not recruiting

Dry Eye SyndromeApproved

Approved

Ocular HypertensionApproved

Active, not recruiting

PresbyopiaPhase 3

Active, not recruiting

CataractPhase 3

Active, not recruiting

XerostomiaApproved

Active, not recruiting

Open-Angle GlaucomaApproved

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

219 competitors in Cataract

#DrugCompanyPhaseTrials

Isopto Carpine

AAdvanz Pharma

Approved

1 2

Pred Forte

Novartis

Phase 3

6 3

Mapracorat

Bayer

Phase 3

4 4

ISV-305

Sun Pharmaceutical Industries Limited

Phase 3

2 5

Ripasudil

KKowa Research Institute, Inc.

Phase 3

2 6

OCS-01

QQuan Dong Nguyen

Phase 3

1 7

Idose TR

GGlaukos Corporation

Phase 3

1 8

Zolymbus

AbbVie

Preclinical

—9

Neurontin

VViatris Specialty LLC

Preclinical

3 10

Ceftin

PPhiladelphia Eye Associates

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 3Recruiting

CAR

NCT03933631

Clinical

Trials by Indication[1]

Xerostomia3 trials

Effect of Pilocarpine in Patients With Xerostomia

Unknown status·UUniversity of Sao Paulo·Phase 4·NCT02982577·80 enrolled

Xerostomia in Patients With a Life-limiting Condition or Frailty

Unknown status·MMaastricht University Medical Center·Phase 3·NCT05506137·120 enrolled

Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Completed·JJeong-seong Kwon·N/A·NCT01627626·60 enrolled

CAR3 trials

Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00618059·28 enrolled

Pilocarpine Use After Kahook Goniotomy

Recruiting·MMontefiore Medical Center·Phase 3·NCT03933631·142 enrolled

Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00601211·28 enrolled

Fasting Conditions2 trials

Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00601874·28 enrolled

Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00602524·28 enrolled

Presbyopia2 trials

Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

Completed·OOcuphire Pharma, Inc.·Phase 2·NCT04675151·150 enrolled

Efficacy of Pilocarpine 1% in Presbyopia

Unknown status·IIsfahan University of Medical Sciences·Phase 3·NCT05578001·25 enrolled

Efficacy2 trials

Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Completed·UUniversity of Kentucky·N/A·NCT01690052·15 enrolled

Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

Completed·EEyenovia Inc.·Phase 3·NCT04657172·84 enrolled

12 more indications

Cataract1 trial

Pilocarpine After Combined Cataract/Trabectome Surgery

Withdrawn·MMontefiore Medical Center·Phase 3·NCT04005079

Lip1 trial

Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat

Completed·UUSDA, Western Human Nutrition Research Center·N/A·NCT02935894·14 enrolled

Single Ascending Dose1 trial

First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology

Completed· Astellas logo

Astellas·Phase 1·NCT02420782·116 enrolled

Head and Neck Cancer1 trial

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 2/3·NCT00656513·196 enrolled

Diabetes1 trial

Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study

Terminated·UUniversity of California, San Diego·N/A·NCT03460964·2 enrolled

Glaucoma1 trial

Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and PEX - a Pilot Study

Unknown status·MMedical University of Vienna·N/A·NCT02865473·90 enrolled

Intraocular Pressure1 trial

The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure

Completed·UUniversity of Colorado, Denver·N/A·NCT02754570·27 enrolled

Oral1 trial

A Study to Investigate the Effect of Oral Doses of Pilocarpine on Salivary Secretion and Static Pupillometry in Healthy Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT02447315·12 enrolled

Tics1 trial

Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects

Completed·TTheraVida, Inc.·Phase 1·NCT01036035·18 enrolled

Treatment1 trial

Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye

Completed·—·N/A·NCT06752278·40 enrolled

Dry Mouth1 trial

Local Pilocarpine for Relieving Dry Mouth

Completed·MMaastricht University Medical Center·Phase 1·NCT04195100·14 enrolled

Unspecified1 trial

Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure

Unknown status·SSun Yat-sen University·N/A·NCT02613013·240 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

OCUSERT PILO-40

NDA NDA017548

Jan 1, 1982

OCUSERT PILO-20

NDA NDA017431

Oct 1, 1984

PILOPINE HS

NDA NDA018796

Mar 22, 1994

SALAGEN

NDA NDA020237

Jun 22, 2010

ISOPTO CARPINE

NDA NDA200890

Oct 28, 2021

VUITY

NDA NDA214028

Oct 17, 2023

QLOSI

NDA NDA217836

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Pilocarpine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Isopto Carpine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pilocarpine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pilocarpine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217836). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Isopto Carpine. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Advanz Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M1 Agonist; Muscarinic Acetylcholine Receptor M3 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAdvanz Pharma

Patent Landscape[6]

Patent Cliff

Aug 18, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11129812Aug 18, 2037

10639297Aug 18, 2037

11974986Aug 18, 2037

9867810Aug 18, 2037

10610518Apr 24, 2039

1 more patents

11285134Apr 24, 2039

Isopto Carpine

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Xerostomia3 trials

CAR3 trials

Fasting Conditions2 trials

Presbyopia2 trials

Efficacy2 trials

Cataract1 trial

Lip1 trial

Single Ascending Dose1 trial

Head and Neck Cancer1 trial

Diabetes1 trial

Glaucoma1 trial

Intraocular Pressure1 trial

Oral1 trial

Tics1 trial

Treatment1 trial

Dry Mouth1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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