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Tadalafil · Adcirca

Small molecule

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Negativelead readout

Evidence outlook · lead readout

NCT01824290 · Hypertension, Pulmonary

The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found. A further registrational readout is expected around 2027-01-31.

NCT01824290: This trial was randomized, double-blind, and placebo-controlled, and it measured a recognized functional outcome (walking distance) in children with pulmonary arterial hypertension. However, although tadalafil-treated children walked further on average, the difference from placebo did not reach statistical significance, so the trial does not show a clear benefit despite its otherwise rigorous design.

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Competitive landscape

64 competitors in this universe: 3 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 8 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Tadalafil (Adcirca): this drugPhase 3Small moleculePDE5
Sildenafil (Revatio)Phase 3Small moleculePDE5
Udenafil (Zydena)Phase 3Small moleculePDE5
RTN-001Phase 2Small moleculePDE5
AR1001Phase 3Small moleculePDE5
Aprocitentan (Tryvio)ApprovedSmall moleculeEndothelin receptor (ETA/ETB, dual)
Baxdrostat (Baxfendy)ApprovedSmall moleculeAldosterone synthase (CYP11B2)
Bosentan (Tracleer)ApprovedSmall moleculeEndothelin receptor (ETA/ETB, dual)
Epoprostenol (Flolan)ApprovedSmall moleculeIP receptor (prostacyclin pathway)
Nitric Oxide (INOmax)ApprovedGas (inhaled)Nitric oxide
Sacubitril / Valsartan (Entresto)ApprovedSmall moleculeNeprilysin + Angiotensin II receptor (dual)
Treprostinil (Orenitram / Remodulin / Tyvaso)ApprovedSmall moleculeIP receptor (prostacyclin pathway)
Treprostinil (Yutrepia, Liquidia)ApprovedSmall moleculeIP receptor (prostacyclin pathway)
AD-209Phase 3Small moleculeAngiotensin II type 1 receptor / L-type calcium channel / Na-Cl cotransporter
AGSAVIPhase 3Small moleculeAngiotensin II receptor / Calcium channel / Thiazide-like diuretic
AJU-C52Phase 3Small moleculeAngiotensin II receptor / Calcium channel / Thiazide-like diuretic

…and 49 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(18 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (4)
November 2026 (3)
Phase 2Duchenne Muscular Dystrophy, Duchenne Disease, Muscular Dystrophy, Muscular Dystrophy in Children, Vasodilation, Exercise, DMDRecruiting
Est. primary completion 2026-11 · NCT06290713 · CT.gov ↗
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Phase 3Fontan PalliationRecruiting
Est. primary completion 2026-11 · NCT05206955 · CT.gov ↗
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Phase 4Erectile DysfunctionRecruiting
Est. primary completion 2026-11 · NCT07642505 · CT.gov ↗
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December 2026 (1)
Phase 4Erectile DysfunctionsRecruiting
Est. primary completion 2026-12 · NCT07391579 · CT.gov ↗
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2027 (7)
January 2027 (2)
Early phase / not applicableSafety, Efficacy, Tamsulosin, Monotherapy, Tadalafil, Lower Urinary Tract Symptoms, Benign Prostatic HyperplasiaRecruiting
Est. primary completion 2027-01-01 · NCT07722884 · CT.gov ↗
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Phase 3HypertensionRecruiting
Est. primary completion 2027-01-31 · NCT05179876 · CT.gov ↗
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February 2027 (1)
Phase 3Prostate Carcinoma, Erectile Function, Genito Urinary CancerRecruiting
Est. primary completion 2027-02-28 · NCT06717711 · CT.gov ↗
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June 2027 (1)
Phase 4Erectile Dysfunction, TadalafilRecruiting
Est. primary completion 2027-06-30 · NCT07753720 · CT.gov ↗
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September 2027 (1)
Phase 4Type 2 Diabetes, Type 2 Diabetes (T2DM)Not yet recruiting
Est. primary completion 2027-09 · NCT07636161 · CT.gov ↗
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October 2027 (1)
Phase 3Pulmonary Hypertension, Chronic Obstructive Pulmonary DiseaseRecruiting
Est. primary completion 2027-10 · NCT05844462 · CT.gov ↗
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November 2027 (1)
Phase 4Acute Urinary Retention, Benign Prostatic Hyperplasia, Benign Prostatic ObstructionRecruiting
Est. primary completion 2027-11 · NCT07654413 · CT.gov ↗
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2028 (5)
March 2028 (1)
Phase 1BPH (Benign Prostatic Hyperplasia)Not yet recruiting
Est. primary completion 2028-03-01 · NCT07466030 · CT.gov ↗
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May 2028 (1)
Early phase / not applicableHypertensionRecruiting
Est. primary completion 2028-05 · NCT06968962 · CT.gov ↗
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August 2028 (1)
Phase 2Alzheimer DiseaseNot yet recruiting
Est. primary completion 2028-08 · NCT07172815 · CT.gov ↗
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September 2028 (1)
Phase 2Erectile DysfunctionNot yet recruiting
Est. primary completion 2028-09 · NCT07537855 · CT.gov ↗
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December 2028 (1)
Phase 2Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer, Urinary Incontinence Following Surgical ProcedureRecruiting
Est. primary completion 2028-12-01 · NCT07576335 · CT.gov ↗
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2029 (2)
February 2029 (1)
Phase 3HypertensionRecruiting
Est. primary completion 2029-02-14 · NCT07245680 · CT.gov ↗
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March 2029 (1)
Phase 2Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension, DyspneaRecruiting
Est. primary completion 2029-03-01 · NCT05937854 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (54)
Phase 2/3 (8)
Phase 2 (39)
Phase 1/2 (7)
Phase 1 (36)
Phase 4 (56)
Early phase / not applicable (30)
Used as active comparator (12)
Appears in other studies (1)