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Data updated: May 26, 2026

AKPENTOLATE (cyclopentolate hydrochloride)

Ophthalmology Approved 1997-01-13

AKPENTOLATE is indicated for the treatment of Mydriasis; Cycloplegia.

Source: FDA Label • RISING
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1997-01-13
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

RISING
Active Ingredient: CYCLOPENTOLATE HYDROCHLORIDE

AKPENTOLATE Approval History

1998
1999
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2001
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2026
Original
New Indication
New Form
Label Update
14 FDA actions from 1997 to 2017
Jul 2017 SUPPL
Label · Labeling
Apr 2015 SUPPL
Label · Labeling
Jul 2012 SUPPL
Label · Labeling

What AKPENTOLATE Treats

2 indications

AKPENTOLATE is approved for 2 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Mydriasis
  • Cycloplegia
Source: FDA Label

AKPENTOLATE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

4

Same indication, different mechanism — what else might this patient receive?

RYZUMVI
FAMYGEN LIFE
2023 1 indic.
ISOPTO ATROPINE
Novartis
2016 3 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to AKPENTOLATE

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CYCLOGYL
CYCLOPENTOLATE HYDROCHLORIDE
2 shared
Novartis
Shared indications:
MydriasisCycloplegia
ISOPTO ATROPINE
ATROPINE SULFATE
2 shared
Novartis
Shared indications:
MydriasisCycloplegia
MYDRIACYL
TROPICAMIDE
2 shared
Novartis
Shared indications:
MydriasisCycloplegia
View all 6 similar drugs Pro
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AKPENTOLATE FDA Label Details

Indications & Usage

AKPENTOLATE is indicated for the treatment of Mydriasis; Cycloplegia.

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Data Sources

FDA Approval: ANDA040165 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.