NDAORALTABLET1 Generic Approved
Approved
Nov 2003
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
21
Data completeness
6/8 — Strong
CIALIS (tadalafil) by Eli Lilly and Company is phosphodiesterase 5 inhibitors [moa]. Approved for phosphodiesterase 5 inhibitor [epc]. First approved in 2003.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CIALIS (tadalafil) is an oral small-molecule phosphodiesterase 5 inhibitor approved in 2003 for erectile dysfunction and other indications. It works by relaxing smooth muscle and increasing blood flow by inhibiting PDE5 enzyme activity. The drug is available as a tablet and represents a foundational therapy in its class.
$6.0MPart D
LOE ApproachingStable
LOE-approaching lifecycle signals portfolio transition focus; brand team likely sized for legacy management and generic defense rather than growth acceleration.
Mechanism of Action
Phosphodiesterase 5 Inhibitors
Pharmacologic Class:
Phosphodiesterase 5 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke)(Stroke-CORE)
Started May 2026
12,750 enrolled
Intracerebral HaemorrhagePaediatric StrokeStroke Acute+2 more
Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation
Started Feb 2026
40 enrolled
Asthma AttackAsthma ControlAsthma Exacerbations+1 more
Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis
Started Dec 2025
600 enrolled
AsthmaCOPD
Actual Use Trial of Tadalafil 5 mg
Started Jan 2025
2,250 enrolled
Erectile Dysfunction
Impact of Dental Desensitization Facilitated by a Child Life Specialist Distress and Cooperation
Started Aug 2024
59 enrolled
DesensitizationDental AnxietyDental Care+2 more
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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.