Oraverse

(Phentolamine)

Phase 3Small molecule

Oraverse is one of 191 small molecule programs targeting Functional Endoscopic Sinus Surgery. It is currently in Phase 3.

Indications

Total Trials

Active Trials

190

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Functional Endoscopic Sinus SurgeryNot yet recruiting

Inflammatory ResponseActive, not recruiting

PreeclampsiaActive, not recruiting

Heart FailureActive, not recruiting

Diabetes Mellitus, Type 1Completed

ObesityActive, not recruiting

Acute Kidney InjuryRecruiting

Functional Endoscopic Sinus SurgeryPreclinical

Not yet recruiting

Inflammatory ResponsePreclinical

Active, not recruiting

PreeclampsiaPreclinical

Active, not recruiting

Heart FailurePreclinical

Active, not recruiting

Diabetes Mellitus, Type 1Preclinical

Completed

ObesityPhase 1

Active, not recruiting

Acute Kidney InjuryPhase 3

Recruiting

Competition

Competitive Landscape

206 competitors in Heart Failure

#DrugCompanyPhaseTrials

Oraverse

LLife Extension Foundation Inc.

Phase 3

1 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Zemplar

Savaysa

Xylocaine

1 8

Tamiflu

CConrado Roberto Hoffmann Filho

Preclinical

1 9

GLP-1

RRigshospitalet, Denmark

Preclinical

2 10

Optimal Medical Therapy

HHelios Health Institute GmbH

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Menopause

NCT06787066

Q4 2027

Phase 1Active, not recruiting

Obesity

NCT03318094

Clinical

Trials by Indication[1]

Obesity2 trials

Role of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity

Active, not recruiting·VVanderbilt University Medical Center·Phase 1·NCT03318094·36 enrolled

Sex Disparities in Hypoxic Sympatholysis and Impact of Obesity

Completed·UUniversity of Missouri-Columbia·Phase 1·NCT04436731·73 enrolled

OSA1 trial

New Perspective on Exploring the Post-apneic BP Surge in Patients With OSA

Unknown status·XXu J·Phase 1·NCT06172998·350 enrolled

Menopause1 trial

Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms

Recruiting·UUniversity of Missouri-Columbia·Phase 1·NCT06787066·75 enrolled

Preeclampsia1 trial

Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia.

Not yet recruiting·—·N/A·NCT06385600·200 enrolled

Heart Failure1 trial

The Effect of Alfa-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure

Unknown status·RRadboud University Medical Center·N/A·NCT00132106

4 more indications

Acute Kidney Injury1 trial

Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI

Recruiting·HHelwan University·Phase 2/3·NCT06286059·60 enrolled

Functional Endoscopic Sinus Surgery1 trial

Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery

Not yet recruiting·—·N/A·NCT06620991·60 enrolled

Islet Transplantation1 trial

Adrenergic System in Islet Transplantation

Active, not recruiting·UUniversity of Pennsylvania·Phase 1·NCT03079921·11 enrolled

Diabetes Mellitus, Type 11 trial

The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II

Completed·RRadboud University Medical Center·Preclinical·NCT06422494·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

REGITINE

NDA NDA008278

May 9, 2008

ORAVERSE

NDA NDA022159

Sep 25, 2023

RYZUMVI

NDA NDA217064

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Phentolamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Phentolamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Phentolamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217064). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Oraverse. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Life Extension Foundation Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: LLife Extension Foundation Inc.

Patent Landscape[5]

Patent Cliff

Jan 31, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11090261Jan 31, 2034

10278918Jan 31, 2034

10772829Jan 31, 2034

12350366Jan 31, 2034

11844858Jan 31, 2034

6 more patents

9795560Jan 31, 2034

12576066Oct 25, 2039

11400077Oct 25, 2039

12201616Oct 25, 2039

12576067Oct 25, 2039

12201615Dec 25, 2039

Oraverse

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Obesity2 trials

OSA1 trial

Menopause1 trial

Preeclampsia1 trial

Heart Failure1 trial

Acute Kidney Injury1 trial

Functional Endoscopic Sinus Surgery1 trial

Islet Transplantation1 trial

Diabetes Mellitus, Type 11 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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