Penbritin-S

(Ampicillin)

Phase 3Small molecule

Bristol-Myers Squibb

Penbritin-S is one of 100 small molecule programs targeting Malnutrition. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MalnutritionActive, not recruiting

DystoniaActive, not recruiting

PneumoniaActive, not recruiting

SepsisActive, not recruiting

MalnutritionPhase 2/Phase 3

Active, not recruiting

DystoniaPhase 1

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

SepsisPhase 2

Active, not recruiting

Competition

Competitive Landscape

547 competitors in Pneumonia

#DrugCompanyPhaseTrials

Penbritin-S

Bristol-Myers Squibb

Phase 3

2 2

Primaxin

Pfizer

Preclinical

2 3

Jakafi

Incyte

Preclinical

1 4

Innohep

Alnylam Pharmaceuticals

Preclinical

1 5

Neutrexin

WWest Japan Thoracic Oncology Group

Preclinical

12 6

Retrovir

BBp Consulting, Inc

Preclinical

2 7

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

2 8

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

2 9

Advil

KKenvue Brands

Preclinical

2 10

Zantac 150

CChattem

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Post-ApprovalActive, not recruiting

Antibiotics

NCT03997266

Q1 2029

Phase 3Not yet recruiting

Antibiotics

NCT05977400

Clinical

Trials by Indication[1]

Pneumonia2 trials

The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

Completed· Pfizer logo

Pfizer·Phase 3·NCT01189487·47 enrolled

A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia

Completed·UUniversity of Oxford·Phase 3·NCT04041791·4,392 enrolled

Randomized Controlled Trial2 trials

A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome

Completed·UUniversity of Chicago·N/A·NCT02477423·27 enrolled

Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial

Unknown status·HHadassah Medical Organization·N/A·NCT01945450·300 enrolled

Azithromycin2 trials

Treatment of ppROM With Erythromycin vs. Azithromycin Trial

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 3·NCT03060473·21 enrolled

Azithromycin for Preterm Pre-labor Rupture of Membranes

Completed·—·N/A·NCT04202380·300 enrolled

Antibiotics2 trials

NICU Antibiotics and Outcomes (NANO) Follow-up Study

Not yet recruiting·SSharp HealthCare·Phase 3·NCT05977400·802 enrolled

NICU Antibiotics and Outcomes Trial

Active, not recruiting·MMichael Morowitz·Phase 4·NCT03997266·802 enrolled

Surgical Site Infection1 trial

Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery

Completed·—·Phase 4·NCT06368102·70 enrolled

8 more indications

Kidney Stone1 trial

A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])

Completed·UUniversity of California, San Diego·Phase 4·NCT02384200·86 enrolled

Malnutrition1 trial

Strategies to Reduce Mortality Among HIV-infected and HIV-exposed Children Admitted With Severe Acute Malnutrition

Unknown status·MMakerere University·Phase 2/3·NCT05051163·300 enrolled

Infection1 trial

Antimicrobial PK in Infants With Suspected or Confirmed Infection

Completed·—··NCT00491426·450 enrolled

Sepsis1 trial

Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Terminated· Pfizer logo

Pfizer·Phase 2·NCT02424734·11 enrolled

Dystonia1 trial

Ampicillin for DYT-1 Dystonia Motor Symptoms

Completed·UUniversity of Florida·Phase 1·NCT01433757·2 enrolled

Ampicillin1 trial

Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients

Completed·SStanford University··NCT02427932·45 enrolled

Percutaneous Nephrolithotomy (PCNL)1 trial

Endourology Disease Group Excellence (EDGE) Consortium: Antibiotics (Abx) for Percutaneous Nephrolithotomy (PCNL) Part 2

Completed·UUniversity of California, San Diego·N/A·NCT02829060·330 enrolled

Bacteremia1 trial

Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester

Completed·FFar Eastern Memorial Hospital··NCT03248973·1 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

PENBRITIN-S

NDA NDA050072

Jan 1, 1982

POLYCILLIN-N

NDA NDA050309

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Ampicillin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ampicillin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ampicillin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050072). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

Penbritin-S

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2029

Trials by Indication[1]

Pneumonia2 trials

Randomized Controlled Trial2 trials

Azithromycin2 trials

Antibiotics2 trials

Surgical Site Infection1 trial

Kidney Stone1 trial

Malnutrition1 trial

Infection1 trial

Sepsis1 trial

Dystonia1 trial

Ampicillin1 trial

Percutaneous Nephrolithotomy (PCNL)1 trial

Bacteremia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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