DFDA

Bosentan

Treatment for Pulmonary Arterial Hypertension

Typical Dosage: 62.5mg twice daily for 4 weeks, then 125mg twice daily

Effectiveness
75%
Safety Score
55%
Clinical Trials
73
Participants
7K

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
55
DangerousModerateSafe
Treatment Details
Dosage Range
62.5mg twice daily for 4 weeks, then 125mg twice daily
Time to Effect
1-3 months
Treatment Duration
Lifetime
Evidence Quality
HIGH
Number Needed to Treat (NNT)
7(Treat 7 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
15(Treat 15 patients to see 1 additional serious adverse event)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$10,000
Monitoring:$6,000
Side Effect Mgmt:$800
Total Annual:$16,800
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOOD
ICER
$85,000/QALY
QALYs Gained
0.25
Outcome-Based Costs
Cost per Responder
$52,500
Cost per Remission
$336,000
Bosentan Outcomes

for Pulmonary Arterial Hypertension

Efficacy Outcomes
Overall Effectiveness
+75%
Response Rate
+32%
Remission Rate
+5%
Common Side Effects
Headache
+18%
Flushing
+8%
Peripheral Edema
+12%
Anemia
+12%
Liver enzyme elevation
+10%

Sources:

nih.gov
nih.gov
nih.gov

WARNING: LIMITED TRIALS AVAILABLE

You can search for trials, but you probably can't join any because the 1% Treaty hasn't passed yet. Most trials are severely limited by lack of funding and bureaucratic barriers. Help change this!

Active Clinical Trials
1 active trial recruiting for Bosentan in Pulmonary Arterial Hypertension

The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension

NCT07013149RECRUITING
View Study
121 participants
OBSERVATIONAL
São Paulo, Brazil
Started: Aug 20, 2025
Completed Clinical Trials
16 completed trials for Bosentan in Pulmonary Arterial Hypertension

Bosentan in Children With Pulmonary Arterial Hypertension

NCT00319267COMPLETEDPHASE3
View Study
36 participants
INTERVENTIONAL
Started: May 1, 2005

Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

NCT00319020COMPLETEDPHASE3
View Study
33 participants
INTERVENTIONAL
Started: Aug 23, 2005

Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension

NCT01223352COMPLETEDPHASE3
View Study
64 participants
INTERVENTIONAL
Started: Mar 8, 2011

BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

NCT00367770COMPLETEDPHASE4
View Study
37 participants
INTERVENTIONAL
Boston, United States +16 more
Started: Jan 1, 2004

Bosentan and Pulmonary Endothelial Function

NCT01721564COMPLETEDNA
View Study
8 participants
INTERVENTIONAL
Started: Apr 1, 2006

FUTURE 3 Study Extension

NCT01338415COMPLETEDPHASE3
View Study
58 participants
INTERVENTIONAL
Aurora, United States +35 more
Started: Mar 8, 2011

Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)

NCT00303459COMPLETEDPHASE4
View Study
334 participants
INTERVENTIONAL
Started: May 1, 2006

Combination Therapy in Pulmonary Arterial Hypertension

NCT00433329COMPLETEDPHASE4
View Study
100 participants
INTERVENTIONAL
Started: Mar 1, 2007

Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

NCT00323297COMPLETEDPHASE4
View Study
105 participants
INTERVENTIONAL
Los Angeles, United States +29 more
Started: Sep 1, 2006

Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

NCT01392469COMPLETEDPHASE3
View Study
21 participants
INTERVENTIONAL
Tampa, United States +10 more
Started: Apr 20, 2011

Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

NCT00581607COMPLETEDPHASE2, PHASE3
View Study
43 participants
INTERVENTIONAL
New York, United States +3 more
Started: Apr 1, 2008

Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan

NCT04991207COMPLETEDPHASE1
View Study
44 participants
INTERVENTIONAL
Berlin, Germany
Started: Feb 6, 2018

Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia

NCT00260819COMPLETEDPHASE1
View Study
20 participants
INTERVENTIONAL
Paris, France
Started: Jan 1, 2006

Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets

NCT06484673COMPLETEDPHASE1
View Study
32 participants
INTERVENTIONAL
Amman, Jordan
Started: Apr 21, 2024

Pulmonary Artery Remodelling With Bosentan

NCT00595049COMPLETEDPHASE4
View Study
11 participants
INTERVENTIONAL
Started: May 1, 2006

The Effect of Tracleer® on Male Fertility

NCT00082186COMPLETEDPHASE4
View Study
22 participants
INTERVENTIONAL
Started: Jul 1, 2003
Showing 20 of 73 total trials