Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate erythromycin across diverse medical indications, including gastroparesis, bronchiectasis, upper gastrointestinal bleeding, brain injuries, childhood mortality, renal insufficiency, and HER-2 positive metastatic breast cancer. Sponsored by academic medical centers, university hospitals, research foundations, and commercial pharmaceutical organizations, these registered protocols encompass completed, actively recruiting, terminated, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06461429 NOT_YET_RECRUITING
Preterm Birth
University of Melbourne
 2025-11-01
NCT06906757 NOT_YET_RECRUITING
PPROM; Preterm
University of Melbourne
 2025-09
NCT06858618 ACTIVE_NOT_RECRUITING
Safety; Antitumor Activity; PK Profile
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
 2023-08-16 PHASE2
NCT06396078 RECRUITING
Preterm Premature Rupture of Membrane; Pregnancy, High Risk; Preterm Birth
Ohio State University
 2024-07-18 PHASE4
NCT06273891 ACTIVE_NOT_RECRUITING
Premature Rupture of Membrane
Inova Health Care Services
 2024-03-08 PHASE3
NCT06948747 COMPLETED
Healthy Participants
AstraZeneca
 2025-05-06 PHASE1
NCT06917872 COMPLETED
Healthy
Boehringer Ingelheim
 2025-04-29 PHASE1
NCT07063082 NOT_YET_RECRUITING
Chronic Rhinosinusitis
Cairo University
 2025-07-07
NCT05328817 UNKNOWN
Preterm Premature Rupture of Membrane
Eastern Virginia Medical School
 2022-05-01
NCT07394725 COMPLETED
Pre-term Premature Rupture of Membranes
District Headquarters Teaching Hospital Sahiwal
 2024-04-01 PHASE1
NCT03024879 UNKNOWN
Healthy; Obesity
Universitaire Ziekenhuizen KU Leuven
 2014-03 PHASE4
NCT06395610 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2024-03-28 PHASE1
NCT05291403 UNKNOWN
Non Small Cell Lung Cancer
Qianfoshan Hospital
 2022-04-06
NCT05995249 COMPLETED
Healthy Volunteers
Takeda
 2023-08-11 PHASE1
NCT03060473 TERMINATED
Preterm Premature Rupture of Membranes (PPROM)
The University of Texas Medical Branch, Galveston
 2017-02-23 PHASE3
NCT04665089 COMPLETED
Sepsis; Septic Shock; Immunoinflammatory Response
Tunis University
 2022-01-01
NCT05797753 COMPLETED
Amyotrophic Lateral Sclerosis; Healthy Volunteer
Sanofi
 2022-02-18 PHASE1
NCT05008926 Recruiting
Brain Injuries
University Hospital Brest
 2022-03-15 Phase 3
NCT04714554 COMPLETED
Healthy
Myovant Sciences GmbH
 2021-01-06 PHASE1
NCT03966066 UNKNOWN
Bronchiectasis
Beijing Children's Hospital
 2019-08
NCT04066231 TERMINATED
Gastric Motility
Prof Dr Jan Tack
 2019-09-07
NCT04254601 COMPLETED
Skin Diseases
Cairo University
 2018-04-01
NCT03883269 RECRUITING
Acne Vulgaris
Centre for Human Drug Research, Netherlands
 2018-03-20 PHASE4
NCT03779360 COMPLETED
Inflammation; Skin
Centre for Human Drug Research, Netherlands
 2018-10-12
NCT03480243 COMPLETED
Pharmacokinetics
UCB Biopharma S.P.R.L.
 2018-03-27 PHASE1
NCT02515565 UNKNOWN
Pneumonia
Universidad de Granada
 2015-09
NCT02354560 UNKNOWN
FAP-Familial Adenomatous Polyposis
michal roll
 2015-06 PHASE4
NCT02528760 COMPLETED
Cirrhosis
Institute of Liver and Biliary Sciences, India
 2015-09-24
NCT02622802 COMPLETED
Pregnancy
University Hospital, Gasthuisberg
 2012-11
NCT02212821 COMPLETED
Healthy Volunteers
Universitaire Ziekenhuizen KU Leuven
 2014-09 PHASE4
NCT02381080 COMPLETED
B-Cell Chronic Lymphocytic Leukemia
Janssen Research & Development, LLC
 2015-05-19 PHASE1
NCT02481219 COMPLETED
Colorectal Cancer Screening
Medtronic - MITG
 2015-05
NCT01716572 UNKNOWN
Gastrointestinal Hemorrhage; Hematemesis
Hospital Universitari de Bellvitge
 2012-02 PHASE3
NCT02362906 UNKNOWN
Pneumonia
Liaoning University of Traditional Chinese Medicine
 2014-04
NCT02175914 UNKNOWN
FAP-Familial Adenomatous Polyposis
michal roll
 2014-06 PHASE4
NCT02005029 COMPLETED
Parkinson's Disease; Levodopa
Virginia Commonwealth University
 2013-04
NCT01668498 COMPLETED
Ras-wildtype Colorectal Cancer
AIO-Studien-gGmbH
 2011-05 PHASE2
NCT02048007 Completed
Childhood Mortality
University of California San Francisco|Bill and Melinda Gates Foundation|Johns Hopkins University|London School of Hygiene and Tropical Medicine
 2014-11 Phase 4
NCT02017379 TERMINATED
Upper Gastrointestinal Bleeding
Texas Tech University Health Sciences Center, El Paso
 2014-06
NCT02633579 COMPLETED
Healthy
Universitaire Ziekenhuizen KU Leuven
 2012-10
NCT02017379 Terminated
Upper Gastrointestinal Bleeding
Texas Tech University Health Sciences Center El Paso
 2014-06 Not Applicable
NCT01946256 COMPLETED
Chlamydia Trachomatis Infection in Pregnancy
Obafemi Awolowo University Teaching Hospital
 2013-10 PHASE2
NCT01825473 UNKNOWN
Gastroesophageal Reflux; Apnea; Bradycardia
University of Virginia
 2012-09
NCT03024879 Unknown status
Healthy|Obesity
Universitaire Ziekenhuizen KU Leuven
 2014-03 Phase 4
NCT01569633 WITHDRAWN
Feeding Disorder; Nutrition Disorder; Infant,Premature
East Tennessee State University
 2011-10
NCT02755064 COMPLETED
Diabetes Mellitus, Type 1
Adil Bharucha
 2010-06 PHASE1
NCT00827216 COMPLETED
Aspiration of Gastric Contents; Gastric Emptying
University Hospital, Geneva
 2009-01 PHASE2
NCT01323582 TERMINATED
Gastroparesis
University of Florida
 2009-02 PHASE2
NCT00467831 TERMINATED
Hermansky-Pudlak Syndrome (HPS); Pulmonary Fibrosis; Oculocutaneous Albinism; Platelet Storage Pool Deficiency; Metabolic Disease
National Human Genome Research Institute (NHGRI)
 2007-04 PHASE1; PHASE2
NCT01556334 WITHDRAWN
Preterm Premature Ruptured Membranes
Indiana University
 2010-04 PHASE3
NCT00589329 TERMINATED
Length of Pregnancy Prolongation in Hours
MetroHealth Medical Center
 2007-12
NCT01659619 COMPLETED
Subtotal Gastrectomy; Stomach Cancer
The Catholic University of Korea
 2012-04 PHASE2
NCT01589614 COMPLETED
Healthy
Pfizer
 2012-06 PHASE1
NCT00718315 COMPLETED
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2009-04 PHASE3
NCT01309438 COMPLETED
Healthy; Renal Insufficiency
Janssen Research & Development, LLC
 2011-02 PHASE1
NCT01379183 COMPLETED
Healthy
Mayo Clinic
 2011-06 PHASE2; PHASE3
NCT00304187 COMPLETED
Bulimia Nervosa; Eating Disorders
New York State Psychiatric Institute
 2004-09 PHASE2
NCT01478256 COMPLETED
Blepharitis
John, George, M.D.
 2011-08 PHASE4
NCT01342198 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2011-06 PHASE1
NCT01117376 TERMINATED
Gastroparesis
Shiraz University of Medical Sciences
 2010-05 PHASE2
NCT01338441 COMPLETED
Cardiology: RR / QT
Ectycell SASU
 2011-03 PHASE1
NCT01631968 COMPLETED
Infection After Primary Total Knee Arthroplasty
Parc de Salut Mar
 2007-09
NCT01097811 UNKNOWN
Hepatic Encephalopathy; Hypertension, Portal; Liver Cirrhosis
UPECLIN HC FM Botucatu Unesp
 2008-06
NCT01401179 COMPLETED
Preterm Premature Rupture of the Membranes
Samsung Medical Center
 2005-04 PHASE3
NCT01060267 COMPLETED
Variceal Bleeding
King Abdulaziz Medical City
 2007-01
NCT00259220 COMPLETED
Upper Gastrointestinal Bleeding
Assistance Publique - Hôpitaux de Paris
 2005-12 PHASE3
NCT00999232 COMPLETED
Pancreatitis
Canisius-Wilhelmina Hospital
 2004-10 PHASE4
NCT00148070 COMPLETED
Metastatic Breast Cancer
University of Michigan Rogel Cancer Center
 1999-03 PHASE2
NCT00146042 COMPLETED
HER-2 Positive Metastatic Breast Cancer
University of Michigan Rogel Cancer Center
 1999-03 PHASE2
NCT02251132 COMPLETED
Healthy
Boehringer Ingelheim
 2000-10 PHASE1
NCT00021671 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00367419 COMPLETED
Bronchiolitis Obliterans; Acute Obliterating Bronchiolitis
Baqiyatallah Medical Sciences University
 PHASE4
NCT00142272 COMPLETED
Cholera
International Centre for Diarrhoeal Disease Research, Bangladesh
 2001-05 PHASE3
NCT00368342 COMPLETED
Asthma
Baqiyatallah Medical Sciences University
 PHASE4
NCT00000120 COMPLETED
Chlamydia Infections; Ophthalmia Neonatorum
National Eye Institute (NEI)
 1985-01 PHASE3
NCT00147667 UNKNOWN
COPD
Royal Free and University College Medical School
 2004-04 PHASE2; PHASE3
NCT00002194 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE1
NCT00318201 COMPLETED
Healthy
Indiana University
 2006-04 PHASE4
NCT00648726 COMPLETED
Pneumonia
Pfizer
 2003-01 PHASE3
NCT00373919 UNKNOWN
Esophagectomy; Postoperative Complications
Kaplan Medical Center
NCT00004564 UNKNOWN
Hypercholesterolemia; Thrombosis
National Center for Research Resources (NCRR)
NCT01323257 COMPLETED
Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland
 2011-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-06-13)

Check the Erythromycin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Erythromycin reversibly binds to the 50S subunit of the bacterial ribosome, thereby blocking translocation during protein synthesis and inhibiting polypeptide elongation. This suppression of essential bacterial protein production leads to bacteriostasis, while also modulating gastrointestinal motility through motilin receptor activation, providing the rationale for clinical studies in conditions such as bronchiectasis and gastroparesis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.