Pentam
(Pentamidine isethionate)ApprovedSmall molecule
Pentamidine isethionate is used to treat and prevent a serious lung infection called PCP (pneumocystis pneumonia) that commonly affects people with weakened immune systems, particularly those with HIV/AIDS. It can be given as an injection or inhaled as a mist into the lungs.[2] Pentam is currently approved and in use across 5 indications[4].[1]
Pentam is one of 70 small molecule programs targeting Trypanosomiasis. It is currently in Approved.
5
Indications
23
Total Trials
1
Active Trials
69
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
123 competitors in HIV Infection
#DrugCompanyPhaseTrials
1Retrovir
BBp Consulting, Inc
Approved
Videx
Bristol-Myers SquibbApproved
Norvir
AbbVieApproved
Pentam
FFresenius Kabi USA, LLC
Approved
Tivicay
GSKApproved
Epivir
GGlaxo Dba Glaxosmithkline
Approved
Ziagen
GSKApproved
Viramune
Boehringer IngelheimApproved
Sustiva
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Approved
Olumiant
Eli LillyApproved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Pneumonia19 trials
Show 16 more trials
A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000727·322 enrolled
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001003·20 enrolled
Aerosols in the Treatment of Asymptomatic Pneumocystis Pneumonia: A Pilot Study Assessing the Effectiveness of Aerosolized Pentamidine as Treatment of Subclinical Pneumocystis Infection in Patients With No Clinical Symptoms
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000707·20 enrolled
A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000974·16 enrolled
Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000730·240 enrolled
Aerosols in the Treatment of Pneumocystis Pneumonia: A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000722·45 enrolled
Cutaneous Leishmaniasis2 trials
Prevention1 trial
A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000991·600 enrolled
Regulatory
FDA Approval Timeline[5]
Oct 16, 1984
PENTAM
NDA NDA019264
Jun 15, 1989
NEBUPENT
NDA NDA019887
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Pentam drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Pentamidine isethionate. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- FFresenius Kabi USA, LLC