IPLEX
LOE ApproachingBLASUBCUTANEOUSINJECTABLEPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 2h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IPLEX is a subcutaneous small-molecule injectable approved by BLA in December 2005 for treatment of coagulation disorders, acute major bleeding, and perioperative bleeding, with additional labeled indications spanning surgical procedures (knee arthroplasty, hepatectomy, liver transplant), infectious diseases (CMV, HIV, community-acquired pneumonia), and inflammatory conditions (vitiligo, autoimmune disease, allergic rhinitis). The mechanism of action and pharmacologic class are not disclosed in available data. The product is sponsored by Insmed and currently approaching loss of exclusivity.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30/100); team size likely stabilizing as exclusivity window narrows.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®)
Started Nov 2021
94 enrolled
Cytomegalovirus InfectionsHIV InfectionsVaccine
Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
Started Jan 2021
255 enrolled
Chronic Pain
Confirmatory Clinical Study of Oxiplex
Started Apr 2018
135 enrolled
Herniated Lumbar Disk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
Started Jun 2017
208 enrolled
Significant Bleeding Risk
A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
Started Dec 2016
450 enrolled
Bladder Cancer
Worked on IPLEX at Insmed? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.