Iheezo

(Chloroprocaine)

ApprovedSmall molecule

Iheezo is a small molecule that works as a Sodium Channel Alpha Subunit Blocker.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Iheezo is one of 157 small molecule programs targeting Pain. It is currently in Approved.

Indications

Total Trials

Active Trials

156

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Macular DegenerationCompleted

Total Knee ArthroplastyActive, not recruiting

CataractApproved

Inguinal HerniaActive, not recruiting

AnesthesiaNot yet recruiting

Blood PressureCompleted

Anesthesia, LocalNot yet recruiting

Labor AnalgesiaNot yet recruiting

Macular DegenerationApproved

Completed

Total Knee ArthroplastyApproved

Active, not recruiting

CataractApproved

Approved

Inguinal HerniaApproved

Active, not recruiting

AnesthesiaApproved

Not yet recruiting

Blood PressurePreclinical

Completed

Anesthesia, LocalApproved

Not yet recruiting

Labor AnalgesiaApproved

Not yet recruiting

Competition

Competitive Landscape

67 competitors in Total Knee Arthroplasty

#DrugCompanyPhaseTrials

Naropin

FFresenius Kabi USA, LLC

Approved

26 2

Cyklokapron

JJ Molner

Approved

25 3

Decadron

AAspen Global Incorporated

Approved

17 4

Medrol

Pfizer

Approved

4 5

Journavx

Vertex Pharmaceuticals

Approved

2 6

Lexapro

AbbVie

Approved

1 7

Epidiolex

Jazz Pharmaceuticals

Approved

1 8

MS Contin

HHikma Pharmaceuticals LLC

Approved

7 9

Celebrex

PPhiladelphia Eye Associates

Approved

6 10

Duragesic

CCephalon

Approved

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

Timeline

Expected Milestones

Q2 2027

Post-ApprovalNot yet recruiting

Total Knee Arthroplasty

NCT07239999

Q3 2027

Post-ApprovalNot yet recruiting

Anesthesia

NCT07348614

Q4 2027

ApprovedNot yet recruiting

Anesthesia, Local

NCT07444827

Clinical

Trials by Indication[1]

Anesthesia3 trials

Epidural Anesthesia With Chloroprocaine Versus Lidocaine

Completed·JJinling Hospital, China·Phase 4·NCT02287870·120 enrolled

Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia

Not yet recruiting·—·Phase 4·NCT07348614·128 enrolled

Optimizing Anesthesia for Post Partum Tubal Ligations

Terminated·UUniversity of Alabama at Birmingham·Phase 2·NCT03993314·15 enrolled

Spinal Anesthesia3 trials

Spinal Anesthesia for Outpatient Abdominal Wall Surgery: Comparison of Bupivacaine, 2-chloroprocaine and Prilocaine

Completed·AAZ St.-Dimpna Geel··NCT02813382·101 enrolled

A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia

Completed·UUniversité de Montréal·N/A·NCT00845962·106 enrolled

Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)

Completed·—·Phase 4·NCT02862912·43 enrolled

Cervical Cerclage2 trials

ED90 of 3% Chloroprocaine for Cervical Cerclage

Completed·—·Phase 4·NCT03805438·47 enrolled

Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Completed·TTufts Medical Center·Phase 4·NCT03305575·10 enrolled

Labor Analgesia1 trial

Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia

Not yet recruiting·WWomen's Hospital School Of Medicine Zhejiang University·Phase 4·NCT06472232·356 enrolled

Epidural Analgesia1 trial

Chloroprocaine for Continuous Epidural Analgesia in Neonates and Infants

Completed·JJoseph D. Tobias··NCT02207855·21 enrolled

10 more indications

Foot Surgery1 trial

The Impact of Chloroprocaine 3% for Ambulatory Foot Surgery on Perioperative Process Costs

Completed·OOspedale Regionale Bellinzona e Valli··NCT02406703·100 enrolled

Inguinal hernia1 trial

Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.

Completed·AAstes·Phase 4·NCT02049255·50 enrolled

Caesarean Section1 trial

Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

Terminated·SSintetica SA·Phase 3·NCT02919072·16 enrolled

Knee Surgery1 trial

Chloroprocaine Spinal for Outpatient Knee Surgery

Terminated·HHospital for Special Surgery, New York·Phase 2·NCT03365752·39 enrolled

Bupivacaine1 trial

Comparison of Clorotekal and Bupivacaine for Short Obstetric Surgery

Suspended·OOregon Health and Science University·Phase 4·NCT03967288·27 enrolled

Arthroplasty1 trial

Intrathecal Chloroprocaine for Lower Limb Arthroplasty

Completed·HHôpital de la Croix-Rousse··NCT05365074·65 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Total Knee Arthroplasty1 trial

Comparing Spinal Anesthesia With 1% Chloroprocaine Versus 1% Mepivacaine in Patients Undergoing Outpatient Primary Total Knee Arthroplasty

Not yet recruiting·NNova Scotia Health Authority·Phase 4·NCT07239999·170 enrolled

Anesthesia, Local1 trial

Study of Targeted Injection of Nerves to the Knee-A Volunteer Trial Evaluating Nerve to Vastus Medialis

Not yet recruiting·DDuke University·Approved·NCT07444827·25 enrolled

Macular Degeneration1 trial

Comparative Evaluation of Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia in a Private Retina Practice

Completed·RRetina Consultants of Delmarva·Approved·NCT07779356·50 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

NESACAINE

NDA NDA009435

Sep 26, 2017

CLOROTEKAL

NDA NDA208791

Sep 27, 2022

IHEEZO

NDA NDA216227

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Chloroprocaine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Chloroprocaine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Chloroprocaine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216227). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Iheezo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — B. Braun Medical Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: BB. Braun Medical Inc.

Patent Landscape[5]

Patent Cliff

Dec 11, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8969412Sep 5, 2026

9504666Dec 11, 2033

10792271Sep 15, 2038

11969403May 14, 2039

Iheezo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Anesthesia3 trials

Spinal Anesthesia3 trials

Cervical Cerclage2 trials

Labor Analgesia1 trial

Epidural Analgesia1 trial

Foot Surgery1 trial

Inguinal hernia1 trial

Caesarean Section1 trial

Knee Surgery1 trial

Bupivacaine1 trial

Arthroplasty1 trial

Blood Pressure1 trial

Total Knee Arthroplasty1 trial

Anesthesia, Local1 trial

Macular Degeneration1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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