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Coly-Mycin M

(Colistin)

ApprovedSmall molecule

Colistin is an antibiotic used to treat serious bacterial infections, particularly those caused by bacteria that are resistant to other common antibiotics. It's often used as a last-resort treatment for difficult-to-treat infections.[2] Coly-Mycin M is currently approved and in use across 14 indications[4].[1]

Coly-Mycin M is one of 317 small molecule programs targeting Bacterial Disease. It is currently in Approved.

14

Indications

34

Total Trials

2

Active Trials

316

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Bacterial DiseaseActive, not recruiting

Bacterial PneumoniaActive, not recruiting

ToxicityActive, not recruiting

MortalityActive, not recruiting

BronchitisApproved

PneumoniaApproved

Pseudomonas InfectionActive, not recruiting

EncephalopathyActive, not recruiting

Septic ShockActive, not recruiting

Cystic FibrosisActive, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Bacterial PneumoniaPhase 3

Active, not recruiting

ToxicityPhase 3

Active, not recruiting

MortalityApproved

Active, not recruiting

BronchitisApproved

Approved

PneumoniaApproved

Approved

Pseudomonas InfectionApproved

Active, not recruiting

EncephalopathyPhase 1

Active, not recruiting

Septic ShockPreclinical

Active, not recruiting

Cystic FibrosisPhase 2

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Coly-Mycin M

Spikevax

Bnt162b2

COVID-19 Vaccine

Biaxin

Stivarga

Aimovig

Aldactone

Nexavar

Singulair

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Ampicillin

NCT05922124

Q1 2028

Phase 3Not yet recruiting

Bacterial Pneumonia

NCT07326540

Clinical

Trials by Indication[1]

Acinetobacter Baumannii3 trials

Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii

Unknown status·HHospitales Universitarios Virgen del Rocío·Phase 3·NCT00645723·67 enrolled

Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii

Unknown status·MMahidol University·Phase 3·NCT01297894·92 enrolled

Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex

Completed·EEntasis Therapeutics·Phase 3·NCT03894046·207 enrolled

Pneumonia3 trials

Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli

Unknown status·MMahidol University·Phase 3·NCT00300560·152 enrolled

Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae

Unknown status·—·Phase 4·NCT04489459·60 enrolled

The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

Completed·NNourhan Hassan Osama Thuraya Mohamed·Phase 2/3·NCT03622450·40 enrolled

Mortality2 trials

Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients

Unknown status·—·Phase 4·NCT02117986·200 enrolled

Impact of Treatment With Colistin on Mortality Bacteremia Multiresistant Acinetobacter Baumannii Sensitive Colistin in Patients Critical

Completed·MMaimónides Biomedical Research Institute of Córdoba··NCT02573064·113 enrolled

Toxicity2 trials

Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity

Unknown status·MMahidol University·Phase 3·NCT01501968·54 enrolled

The Effect of Curcumin Against Colistin-induced Nephrotoxicity

Unknown status·OOctober 6 University·Phase 3·NCT05613361·214 enrolled

Infection1 trial

A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Completed·AAchaogen, Inc.·Phase 3·NCT01970371·69 enrolled

22 more indications

Minocycline1 trial

Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Carbapenem-Resistant A. Baumannii Infection

Unknown status·MMahidol University·Phase 4·NCT05586815·94 enrolled

Antibiotic-resistant Bacteria1 trial

Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy

Unknown status·SStephen Harbarth·Phase 2·NCT02472600·39 enrolled

Prevention1 trial

Nebulized Colistin for Gram Negative VAP Prevention.

Unknown status·UUniversity of Thessaly·N/A·NCT04208945·152 enrolled

Bacterial Pneumonia1 trial

Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex

Not yet recruiting·BBioVersys AG·Phase 3·NCT07326540·248 enrolled

Septic Shock1 trial

A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04208763·90 enrolled

COVID-191 trial

Aerosolized Versus Intravenous Colistin-based Antimicrobial Regimens in Hospitalized COVID-19 Patients With Bacterial Coinfection: A Randomized Controlled Trial

Completed·—·Phase 3·NCT05689229·128 enrolled

Cystic Fibrosis1 trial

Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

Completed·UUniversity of Jena·Phase 2·NCT01035853·10 enrolled

Ampicillin1 trial

Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii

Recruiting·RRambam Health Care Campus·Phase 4·NCT05922124·734 enrolled

Encephalopathy1 trial

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients

Unknown status·MMadonna Magdy Fahmy·Phase 1·NCT05279586·316 enrolled

Extracorporeal Membrane Oxygenation1 trial

Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation

Terminated·SSt. Anne's University Hospital Brno, Czech Republic·Phase 4·NCT05542446·8 enrolled

Prophylaxis1 trial

Comparative Study of Secondary Prophylaxis for SBP

Completed·TTanta University·Phase 4·NCT06827756·90 enrolled

Enterobacteriaceae Infections1 trial

Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections

Terminated·KKing Faisal Specialist Hospital & Research Center·Phase 3·NCT05258851·29 enrolled

Renal Replacement Therapy1 trial

Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

Unknown status·UUniversity of Zurich·Phase 4·NCT02081560·10 enrolled

Ventilator-Associated Pneumonia1 trial

Trial of Colistin Versus Meropenem in Ventilator-associated Pneumonia (VAP) (CR-GNB)

Completed·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla·Phase 3·NCT01292031·232 enrolled

OSA1 trial

Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii

Unknown status·MMahidol University·Phase 3·NCT01297855·130 enrolled

Safety and Efficacy1 trial

IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy

Completed·NNational Jewish Health·Phase 4·NCT02918409·51 enrolled

Intravenous Administration1 trial

Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 4·NCT04995133·20 enrolled

Randomized Controlled Trial1 trial

Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem

Completed·MMical Paul·Phase 4·NCT01732250·406 enrolled

Bronchitis1 trial

Tracheobronchitis Prevention Trial

Completed·UUniversity of Thessaly·N/A·NCT01025921·84 enrolled

Intravenous1 trial

Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates

Terminated·HHat Yai Medical Education Center·Phase 3·NCT02806141·204 enrolled

Clinical Response1 trial

Colistin Versus Colistin Combined With Cefoperazone-sulbactam for Multiresistant Acinetobactor Baumannii Ventilator-associated Pneumonia Treatment

Completed·SShaheed Mohtarma Benazir Bhutto Institue of Trauma·Preclinical·NCT07671755·80 enrolled

Unspecified2 trials

Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

Completed·UUniversity Hospital Tuebingen·Phase 3·NCT03341741·26 enrolled

Colistin and Rifampicin for MDR-Acinetobacter

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 3·NCT01577862·210 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

COLY-MYCIN S

NDA NDA050355

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Colistin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Coly-Mycin M drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Colistin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Colistin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050355). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Parkedale company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PParkedale

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