TEKTURNA
Post-LOEaliskiren hemifumarate
NDAORALTABLET
Approved
Mar 2007
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
3
Data completeness
6/8 — Strong
TEKTURNA (aliskiren hemifumarate) is perfusion. Approved for hypertension in adults, greater, to lower blood pressure and 1 more indications. First approved in 2007.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEKTURNA (aliskiren hemifumarate) is an oral direct renin inhibitor approved in 2007 for hypertension in adults. It works by blocking renin at the top of the renin-angiotensin-aldosterone system (RAAS), preventing conversion of angiotensinogen to angiotensin I and reducing downstream vasoconstrictors and aldosterone secretion. This novel mechanism distinguishes it from ACE inhibitors and ARBs, which act downstream in the pathway.
$0.001BPart D
Post-LOEDeclining
Post-LOEProduct is in mature/post-LOE phase with minimal Part D spending ($1M in 2023, 1,580 claims), indicating a contracted brand team and primarily defensive sales strategy.
Mechanism of Action
perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by ACE and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla…
Indications (4)
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.