NDAINTRA-ANALOINTMENTPriority Review
Approved
Jun 2011
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
4/8 — Partial
Priority Review
RECTIV (nitroglycerin) by AbbVie is (no) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic gmp) in smooth muscle and other tissues. First approved in 2011.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RECTIV is a nitroglycerin ointment administered intra-anally to treat anal fissures through nitrate-mediated vasodilation. The drug works by releasing nitric oxide (NO), which activates guanylate cyclase and increases cyclic GMP in smooth muscle, leading to relaxation of the internal anal sphincter and pain relief. It is the only FDA-approved topical nitrate for this indication.
$0.006BPart D
PeakRECTIV is at peak lifecycle with modest Part D spending ($6M in 2023), indicating a small but established patient base requiring focused commercial execution and niche specialty expertise.
Mechanism of Action
(NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation.
Pharmacologic Class:
Nitrate Vasodilator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease
Started Oct 2026
36 enrolled
Stable Coronary Artery Disease
A Nurse-led Patient-centred Intervention to Increase Written Advance Directives
Started Oct 2019
0Advance Care PlanningOutpatientsPalliative Care
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
Started May 2016
12 enrolled
KyphosisSpinal Fractures
Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients
Started Nov 2015
36 enrolled
Coronary Artery Disease
Safety of Nitroglycerin for Field Treatment of STEMI
Started Jun 2015
940 enrolled
Myocardial Infarction
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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.