TEKTURNA
Peakaliskiren hemifumarate
NDAORALCAPSULE, PELLETPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
TEKTURNA (aliskiren hemifumarate) is perfusion. Approved for hypertension in adults, greater, to lower blood pressure and 1 more indications. First approved in 2017.
Drug data last refreshed 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEKTURNA (aliskiren hemifumarate) is an oral direct renin inhibitor used to treat hypertension in adults. It works by blocking the conversion of angiotensinogen to angiotensin I at the earliest step of the renin-angiotensin-aldosterone system (RAAS), thereby reducing plasma renin activity and downstream vasoconstrictors. Unlike ACE inhibitors and ARBs, aliskiren's mechanism prevents compensatory renin rise from overwhelming therapeutic effect.
Post-LOE
Declining
Product is in post-LOE phase with minimal current spending ($1M), indicating a contracted team focused on maintenance and niche positioning rather than growth.
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.