NDAINJECTIONINJECTABLE
Approved
Mar 1952
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
4/8 — Partial
ACTH (corticotropin) by Pfizer is gram-negative coccobacillus. First approved in 1952.
Drug data last refreshed 20h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTH (Corticotropin) is a synthetic adrenocorticotropic hormone indicated for immunization against Haemophilus influenzae type b (Hib) when formulated as ActHIB vaccine. It stimulates the immune system to produce anti-PRP antibodies that provide long-term protection against invasive Hib disease in infants and children. The vaccine induces a T-dependent immune response with prominent IgG isotype antibodies and demonstrated bactericidal activity.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); brand team likely focused on transition planning and lifecycle extension strategies.
Mechanism of Action
gram-negative coccobacillus. Most strains of H. influenzae that cause invasive disease (e.g., sepsis and meningitis) are H. influenzae type b. The response to ActHIB vaccine is typical of a T-dependent immune response to antigens. The prominent isotype of anti-capsular PRP antibody induced by…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension
Started Jun 2024
48 enrolled
Uncontrolled Hypertension
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Started Jun 2023
160 enrolled
Cushing s Syndrome
A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy
Started Mar 2023
148 enrolled
Primary Membranous Nephropathy
Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation
Started Feb 2019
15 enrolled
FSGS
Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
Started Jul 2017
40 enrolled
Rheumatoid Arthritis (RA)
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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.