Mestinon

(Pyridostigmine)

ApprovedSmall molecule

UUnited BioPharma

Mestinon is one of 32 small molecule programs targeting HIV. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HIVCompleted

Orthostatic HypotensionEnrolling by invitation

HIVPreclinical

Completed

Orthostatic HypotensionPhase 2

Enrolling by invitation

Competition

Competitive Landscape

44 competitors in HIV

#DrugCompanyPhaseTrials

Tivicay

GSK

Approved

5 2

Cabenuva

GSK

Approved

2 3

Sustiva

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

6 4

Pifeltro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

—5

Epivir

GGlaxo Dba Glaxosmithkline

Phase 3

10 6

Mestinon

UUnited BioPharma

Approved

1 7

INCMGA00012

Incyte

Phase 3

1 8

Fostemsavir

GSK

Phase 3

1 9

Selzentry

GSK

Phase 2

4 10

Daraprim

FFondazione Matilde Tettamanti Menotti De Marchi Onlus

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Trial

NCT06366724

Q1 2027

Phase 2Recruiting

Tachycardia

NCT00409435

Clinical

Trials by Indication[1]

Myasthenia Gravis2 trials

Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia Gravis

Unknown status·UUniversity of Aarhus·Phase 4·NCT03510546·44 enrolled

Pyridostigmine and Amifampridine for Myasthenia Gravis

Unknown status·LLeiden University Medical Center·Phase 3·NCT05919407·24 enrolled

Trial2 trials

SPACE Trial: Pyridostigmine vs Placebo in SMA Types 2, 3 and 4

Completed·UUMC Utrecht·Phase 2·NCT02941328·39 enrolled

LIFT: Life Improvement Trial

Recruiting·—·Phase 2·NCT06366724·160 enrolled

Constipation1 trial

Use of Pyridostigmine for Constipation in Diabetics

Completed·MMayo Clinic·Phase 1/2·NCT00276406·30 enrolled

Fibromyalgia1 trial

Testing Mestinon and Exercise in Fibromyalgia

Completed·OOregon Health and Science University·Phase 2·NCT00535587·178 enrolled

Cognition1 trial

Cardiovagal Baroreflex Deficits Impair Neurovascular Coupling and Cognition in POTS

Completed·NNew York Medical College·Phase 1·NCT03261570·51 enrolled

9 more indications

Tachycardia1 trial

A Study of Pyridostigmine in Postural Tachycardia Syndrome

Recruiting·MMayo Clinic·Phase 2·NCT00409435·50 enrolled

Immune Response1 trial

Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response

Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 2·NCT00518154·7 enrolled

Neuropathy1 trial

Autonomic Neuropathy, GI Motility, and Inflammation in HIV

Completed·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT02850276·76 enrolled

Headache1 trial

Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Completed·—·Phase 4·NCT05969119·30 enrolled

Systemic Sclerosis1 trial

Clinical Usefulness and Influence on Esophageal Motility of Pyridostigmine for Dysphagia in Systemic Sclerosis

Withdrawn·UUniversitair Ziekenhuis Brussel·Phase 2·NCT06915181

Transurethral Resection1 trial

The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder.

Completed·MMenoufia University·Phase 4·NCT06753071·66 enrolled

HIV1 trial

Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

Completed·IIcahn School of Medicine at Mount Sinai·Preclinical·NCT04353778·215 enrolled

Orthostatic Hypotension1 trial

Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension

Enrolling by invitation·MMayo Clinic·Phase 2·NCT01370512·30 enrolled

Unspecified2 trials

AchE Inhibitor and Insulin

Completed·UUniversity of Miami·Phase 1·NCT03063515·12 enrolled

Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

Completed·HHospital de Clinicas de Porto Alegre·N/A·NCT00953914·40 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

MESTINON

NDA NDA015193

Jan 1, 1982

MESTINON

NDA NDA009830

Jan 1, 1982

MESTINON

NDA NDA009829

Jan 1, 1982

MESTINON

NDA NDA011665

Jan 1, 1982

REGONOL

NDA NDA017398

Feb 5, 2003

PYRIDOSTIGMINE BROMIDE

NDA NDA020414

Oct 4, 2024

PYRIDOSTIGMINE BROMIDE

NDA NDA217604

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Pyridostigmine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pyridostigmine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pyridostigmine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217604). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Mestinon. U.S. Food & Drug Administration.
[6]
SEC EDGAR — United BioPharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: UUnited BioPharma

Patent Landscape[5]

Patent Cliff

Jun 18, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11478425Jun 18, 2038

12042559Jun 18, 2038

10925833Jun 18, 2038

12233166Jun 18, 2038

10987311Jun 18, 2038

4 more patents

10881617Jun 18, 2038

11666536Jun 18, 2038

11911515Jun 18, 2038

11229606Jun 18, 2038

Mestinon

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Myasthenia Gravis2 trials

Trial2 trials

Constipation1 trial

Fibromyalgia1 trial

Cognition1 trial

Tachycardia1 trial

Immune Response1 trial

Neuropathy1 trial

Headache1 trial

Systemic Sclerosis1 trial

Transurethral Resection1 trial

HIV1 trial

Orthostatic Hypotension1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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