Miochol

(Acetylcholine)

ApprovedSmall molecule

Miochol is a small molecule that works as a Muscarinic Acetylcholine Receptor M3 Agonist.[2] It is being used across 17 indications, with its most advanced program in Approved.[1]

Miochol is one of 406 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

405

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Coronary Artery DiseaseApproved

HIV InfectionApproved

Endothelial DysfunctionApproved

Gestational DiabetesActive, not recruiting

IschemiaApproved

GlaucomaActive, not recruiting

Chest PainActive, not recruiting

Uterine FibroidActive, not recruiting

Anemia (phenotype)Approved

CataractActive, not recruiting

Coronary Artery DiseaseApproved

Approved

HIV InfectionApproved

Approved

Endothelial DysfunctionApproved

Approved

Gestational DiabetesPhase 1

Active, not recruiting

IschemiaApproved

Approved

GlaucomaApproved

Active, not recruiting

Chest PainPreclinical

Active, not recruiting

Uterine FibroidPreclinical

Active, not recruiting

Anemia (phenotype)Approved

Approved

CataractApproved

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Miochol

BBausch Health Americas, Inc.

Approved

34 2

Resotran

Takeda

Preclinical

1 3

Inapsine

Jazz Pharmaceuticals

Preclinical

1 4

Depakote

Ibrance

Lunesta

3 7

Luvox

SSolvay Pharmaceuticals

Preclinical

1 8

Catapres

Boehringer Ingelheim

Preclinical

1 9

Rapamune

PPrism Pharmaceuticals

Preclinical

1 10

Persantine

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Hot Flashes

NCT05193968

Q1 2027

Phase 1Active, not recruiting

Endothelial Function

NCT06499844

Recruiting

Endothelial Function

NCT06443151

Q2 2027

Phase 1Recruiting

Gestational Diabetes

NCT05946785

Q3 2027

Phase 1Recruiting

Vascular Function

NCT05653973

Clinical

Trials by Indication[1]

Endothelial Function3 trials

The Effect of Lopinavir/Ritonavir on Endothelial Function

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00076414·30 enrolled

Role of Endothelial Function in SCI CVD Risk

Recruiting·—··NCT06443151·60 enrolled

Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation

Active, not recruiting·UUniversity of Iowa·Phase 1·NCT06499844·56 enrolled

Sickle Cell Disease3 trials

Atorvastatin Therapy to Improve Endothelial Function in Sickle Cell Disease

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00072826·44 enrolled

Niacin to Improve Blood Flow in People With Sickle Cell Disease

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00508989·30 enrolled

Nitric Oxide to Improve Blood Flow in Sickle Cell Disease

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT00009581·65 enrolled

Vasodilation2 trials

Bevacizumab and Endothelium Dependent Vasodilation

Completed·RRadboud University Medical Center·N/A·NCT01125943·24 enrolled

Pyridoxine, P2 Receptor Antagonism, and ATP-mediated Vasodilation in Young Adults

Completed·—·Phase 1·NCT03738943·9 enrolled

Chronic Kidney Disease2 trials

Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

Terminated· GSK logo

GSK·Phase 2·NCT03446612·6 enrolled

Evaluating the Effect of Standard-of-care Erythropoiesis-stimulating Agents on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.

Completed·—··NCT02987465·29 enrolled

Gestational Diabetes2 trials

Role of Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

Recruiting·AAnna Stanhewicz, PhD·Phase 1·NCT05946785·28 enrolled

Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

Active, not recruiting·AAnna Stanhewicz, PhD·Phase 1·NCT05946798·40 enrolled

22 more indications

Injury1 trial

Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation

Terminated·GGladwin, Mark, MD·Phase 1·NCT01848301·12 enrolled

Pulmonary Hypertension1 trial

Sildenafil to Treat HIV-Associated Pulmonary Hypertension

Terminated·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT00327080·20 enrolled

Humans1 trial

Endothelial Hyperpolarization in Humans

Terminated·EEmory University·Phase 2·NCT00166166·174 enrolled

Hot flashes1 trial

Hot Flashes and Neurovascular Function in Women

Recruiting·MMayo Clinic·N/A·NCT05193968·120 enrolled

Microcirculation1 trial

Mechanisms of Human Cutaneous Microcirculation in Healthy Volunteers

Completed·UUniversity Hospital, Angers··NCT00152724·85 enrolled

Vascular Function1 trial

Prenatal Aspirin and Postpartum Vascular Function

Recruiting·—·Phase 1·NCT05653973·60 enrolled

Preconditioning1 trial

The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT00250185·135 enrolled

Vascular Dysfunction1 trial

Targeting ER Stress in Vascular Dysfunction

Terminated·—·Phase 1·NCT04001647·17 enrolled

Drug1 trial

The Effects of Iontophoresed Vasoactive Drugs on Cutaneus Blood Flow

Unknown status·UUniversity Hospital, Linkoeping·N/A·NCT04777383·90 enrolled

Chest pain1 trial

Blood Markers for Inflammation and Coronary Artery Vasoreactivity Testing in Patients With Chest Pain and Normal Coronary Arteries

Unknown status·SSt George's Healthcare NHS Trust·N/A·NCT01162824·50 enrolled

Aging1 trial

Early Neurovascular Adaptations in Aging Women

Recruiting·UUniversity of Missouri-Columbia·Phase 1·NCT06520982·64 enrolled

Exercise Training1 trial

Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training

Withdrawn·—·Phase 1·NCT03972683

Ischemia1 trial

Adenosine Receptors Influence Ischemia-Reperfusion Injury

Suspended·RRadboud University Medical Center·N/A·NCT00184847·8 enrolled

Uterine Fibroid1 trial

Vascular Function and Uterine Fibroids

Completed·MMayo Clinic··NCT02123069·28 enrolled

Terminated·PPenn State University·Phase 1/2·NCT03953326·2 enrolled

Systemic1 trial

Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation

Completed·UUniversity of Edinburgh·N/A·NCT00901719·12 enrolled

Type 2 Diabetes Mellitus1 trial

Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus

Completed· Sanofi logo

Sanofi·Phase 1·NCT03462017·54 enrolled

Estrogen1 trial

Effects of Continuous Estrogen on Human in Vivo Microvascular Function

Active, not recruiting·MMedical College of Wisconsin··NCT06043310·45 enrolled

Unspecified1 trial

Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva

Completed·SSemmelweis University·N/A·NCT04918563·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

MIOCHOL

NDA NDA016211

Sep 22, 1993

MIOCHOL-E

NDA NDA020213

Aug 18, 1995

MIOCHOL-E

NDA NDA020213

Feb 29, 1996

MIOCHOL-E

NDA NDA020213

Oct 16, 1996

MIOCHOL-E

NDA NDA020213

Apr 29, 1998

MIOCHOL-E

NDA NDA020213

Jan 24, 2000

MIOCHOL-E

NDA NDA020213

May 30, 2006

MIOCHOL-E

NDA NDA020213

Jun 17, 2016

MIOCHOL-E

NDA NDA020213

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Acetylcholine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Acetylcholine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Acetylcholine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020213). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M3 Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Miochol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Endothelial Function3 trials

Sickle Cell Disease3 trials

Vasodilation2 trials

Chronic Kidney Disease2 trials

Gestational Diabetes2 trials

Injury1 trial

Pulmonary Hypertension1 trial

Humans1 trial

Hot flashes1 trial

Microcirculation1 trial

Vascular Function1 trial

Preconditioning1 trial

Vascular Dysfunction1 trial

Drug1 trial

Chest pain1 trial

Aging1 trial

Exercise Training1 trial

Ischemia1 trial

Uterine Fibroid1 trial

Function1 trial

ESS1 trial

Type 2 Diabetes1 trial

Cancer1 trial

Systemic1 trial

Type 2 Diabetes Mellitus1 trial

Estrogen1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News