Celiprolol: A Beta-Blocker Studied for Vascular Ehlers-Danlos Syndrome

Table of Contents

1. What Celiprolol Is
2. Its Original Use in Blood Pressure and Angina
3. Why It Was Tried in Vascular Ehlers-Danlos Syndrome
4. The BBEST Trial
5. The 2019 French Cohort
6. Results From Other Clinics
7. The 2025 Irbesartan Add-On Trial
8. Approval Status in the United States and Elsewhere
9. Side Effects and Safety as Reported
10. What Is Not Known
11. Key Research Papers
12. Connections
13. Featured Videos

What Celiprolol Is

Celiprolol belongs to the beta-blocker family, the medicines that blunt the effect of adrenaline on the heart. Most beta-blockers simply block. Celiprolol does two things at once. The 2010 trial report describes it as a beta-1 receptor blocker with a beta-2 receptor agonist action: it blocks the beta-1 receptors that speed up and strengthen the heartbeat, while mildly stimulating the beta-2 receptors that relax the muscle in blood-vessel walls and airways.

Two early drug reviews, from 1987 and 1991, describe it in the same terms: a "cardioselective" beta-blocker (one that acts mainly on the heart) with partial agonist activity and a weak blood-vessel-widening effect. The 1991 review adds that it is hydrophilic, meaning it dissolves in water rather than fat. A 2017 review proposed calling it a "selective adrenoceptor modulator" rather than a plain beta-blocker, because of this mixed action.

A 1992 study in eight healthy men showed the two sides of the drug directly. At rest, a single 200 mg dose slightly raised resting heart rate and systolic blood pressure, a sign of its partial stimulating effect on beta-1 receptors. At 400 mg and 800 mg a beta-2 effect appeared as a measurable increase in finger tremor. During exercise, celiprolol blocked the rise in heart rate less than atenolol did, and the blockade did not increase beyond 400 mg.

The 2017 review, read in full text, reports that celiprolol is barely broken down by the body and leaves mainly unchanged in urine and stool, with a half-life of about 4 to 5 hours. It also reports that the share of a dose absorbed rises with dose: about 30% at 100 mg and about 70% at 300 to 400 mg.

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Its Original Use in Blood Pressure and Angina

Celiprolol was developed for high blood pressure and angina (chest pain from a heart short of blood). In early trials summarized in the 1987 review, celiprolol 200 to 600 mg once daily worked about as well as propranolol 40 to 80 mg twice daily or atenolol 100 mg once daily in people with mild to moderate high blood pressure or angina. The 1991 review reached the same conclusion for 200 to 400 mg once daily, compared with usual doses of propranolol, atenolol, metoprolol and pindolol. It also reported a slightly favorable effect on blood fats and no apparent harm to blood-sugar handling.

The reviewers of that era wrote that celiprolol would be "a definite advance" only if its apparent advantages were confirmed in well-designed long-term trials. One such test came in heart failure. In the CELICARD trial, published in 2000, 132 people with weak heart pumping were randomly assigned to celiprolol (up to 100 mg) or placebo for one year. Celiprolol did not improve the main measure, functional class. The authors suggested that its beta-2 stimulating property may be a disadvantage in heart failure, and they described its safety profile in that trial as excellent.

The 2017 review states that celiprolol is approved in many countries for heart and blood-vessel conditions. More detail on the underlying condition is on the Hypertension page.

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Why It Was Tried in Vascular Ehlers-Danlos Syndrome

Vascular Ehlers-Danlos syndrome is caused by changes in the COL3A1 gene, which carries the instructions for type III collagen, a main structural protein of artery walls, the bowel and the womb. With faulty type III collagen, these tissues are fragile. Arteries can dissect (split along the wall) or rupture, often in early adulthood, and the bowel and the pregnant womb can tear. The 2010 trial report noted that no preventive treatment had yet been shown to work.

The reasoning behind celiprolol, as the 2017 review describes it, was mechanical. By lowering heart rate and the pulse-by-pulse surge of pressure against the artery wall, celiprolol might reduce the repeated stress on weak collagen fibers. Its mild blood-vessel-widening effect was another point in its favor. The aim was not deep blood-pressure lowering but a gentler load on the wall with every heartbeat.

Animal studies came later and point in different directions:

• In a 2020 study in mice carrying a vascular Ehlers-Danlos syndrome gene change, four weeks of celiprolol increased the force needed to tear rings of the aorta in the laboratory, and so did the antibiotic doxycycline; losartan, an angiotensin II receptor blocker, produced no significant change in mice.
• In a 2022 study in a different mouse model, neither celiprolol nor propranolol changed survival in mice compared with water. Losartan had a large protective effect in mice that disappeared when it was stopped, and added angiotensin II was harmful. The authors concluded that blocking the renin-angiotensin hormone system deserved testing in people.

These are mouse results and do not show what happens in people. The human evidence follows.

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The BBEST Trial

The Beta-Blockers in Ehlers-Danlos Syndrome Treatment (BBEST) trial, published in 2010, was the first randomized trial of any drug in vascular Ehlers-Danlos syndrome. It ran in eight centers in France and one in Belgium.

• Who took part: 53 people with a clinical diagnosis of vascular Ehlers-Danlos syndrome. 33 of them had a confirmed COL3A1 gene change.
• Design: randomized and open (everyone knew who was taking the drug), but the artery events were judged by assessors who did not know the treatment group. 25 people were assigned to celiprolol and 28 to no treatment, for a planned five years.
• Dosing: the trial gave celiprolol twice daily and raised the dose in 100 mg steps every 6 months to a maximum of 400 mg a day; the abstract records side effects after starting 100 mg. In 2016 the journal published a correction for a dosing error in the original abstract and article text (doi:10.1016/S0140-6736(16)31221-1), and the PubMed abstract was corrected to this wording. A 2025 systematic review summarizes the regimen as starting at 100 mg a day and rising to 400 mg.
• Result: the trial was stopped early for benefit after a mean follow-up of 47 months. Artery ruptures or dissections, fatal or not, occurred in 5 of 25 people on celiprolol (20%) and 14 of 28 untreated people (50%). The hazard ratio was 0.36 (95% confidence interval 0.15 to 0.88; p = 0.040), meaning the rate of events in the celiprolol group was about a third of that in the untreated group over the trial period.
• Side effects: one person had severe fatigue after starting 100 mg, and two had mild fatigue as the dose was raised.

The authors wrote that celiprolol "might be the treatment of choice" for preventing major complications, and that whether people with the same clinical picture but no gene change are also protected "remains to be established." The trial was small, it had no placebo, and it was stopped early; trials stopped early for benefit can overstate an effect. These limits are the main reason later reviews describe the evidence as limited.

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The 2019 French Cohort

The Paris national referral center that led the trial then published its long-term experience. This was a retrospective observational study: it looked back at patients' records rather than assigning treatments.

• 144 people with gene-confirmed vascular Ehlers-Danlos syndrome were included between 2000 and 2017. Their median age at diagnosis was 34.5 years, and 91 were the first person diagnosed in their family.
• After the first assessment, patients were treated, or advised to be treated, with celiprolol up to 400 mg a day alongside usual care, with yearly follow-up.
• Median follow-up was 5.3 years. By the end, 90.3% were taking celiprolol alone or with other drugs.
• Overall survival was 71.6% (95% confidence interval 50% to 90%) and depended on the type of COL3A1 change, age at diagnosis and medical treatment.
• More than two-thirds of patients had no new clinical event during follow-up, although 51% already had artery events or artery lesions when diagnosed.
• People treated with celiprolol survived longer than others (p = 0.0004). The lower death rate was dose-related: survival was best at 400 mg a day compared with less than 400 mg (p = 0.003).
• The ratio of hospital stays for sudden artery events to hospital stays for planned check-ups changed significantly after 2011.

Because no one was randomly assigned, these results cannot separate the effect of celiprolol from other differences. People who reach and tolerate the full dose may differ from those who do not, and the whole cohort received specialist surveillance. The authors concluded that overall medical care "seems to have a positive influence."

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Results From Other Clinics

Several other centers have reported their own patients on celiprolol. All are observational, and none had an untreated comparison group.

• Sweden (2021): the Uppsala national referral center offered celiprolol to 40 people with a COL3A1 gene change between 2011 and 2019, twice daily up to 400 mg a day. Median follow-up was 22 months. Of 38 people whose dose-raising was complete, 26 reached the 400 mg target; six could not raise the dose because of side effects, and five of them stopped treatment. There were five major artery events, four of them fatal. The yearly risk of a major artery event was 4.7%, similar to the treated group in the BBEST trial (5%) and lower than its untreated group (12%).
• Italy (2024): a Brescia referral center followed 26 people for a mean of 72 months between 2011 and 2023. At the last visit all were taking celiprolol, 80% at the maximum dose, and the authors described the drug as well tolerated overall. Still, the yearly risk of symptomatic artery events was 8.8%, and most of those events happened after the maximum dose had been reached.
• Japan (2026): the first cohort from outside Europe included 26 adults treated between 2000 and 2024, followed for a mean of 96.6 months. 61.5% reached 400 mg a day. One person died of a ruptured liver artery, 11 had artery events and 14 had none. Event rates were not linked to gene type or celiprolol dose. In interviews with 11 patients, celiprolol was described as giving emotional reassurance and a more active approach to managing the disease.
• United Kingdom (2023): the Sheffield national diagnostic service, reporting on 180 patients, stated that evidence for drug therapy is limited. Its look back at 126 patients found fewer artery events in those on a long-term angiotensin II receptor blocker and/or a beta-blocker than in those on no heart medicine, when all received the same lifestyle and emergency-care advice.
• Pooled view (2025): a systematic review covering 323 participants in studies from 2010 to 2023, mostly European, concluded that celiprolol appears promising and noted varying responses and side effects such as dizziness and low blood pressure.

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The 2025 Irbesartan Add-On Trial

The second randomized trial in vascular Ehlers-Danlos syndrome did not test celiprolol itself. It asked whether adding irbesartan, an angiotensin II receptor blocker, helps people already on celiprolol. It was the first placebo-controlled trial in the condition.

• Who took part: 57 adults on stable celiprolol at French centers. 29 were assigned to irbesartan and 28 to placebo (dummy pills).
• Dosing: the trial gave irbesartan 150 mg a day, raised to 300 mg a day, for 2 years.
• What was counted: any fatal or non-fatal artery event, or any new or worsening artery lesion seen on scheduled head-to-pelvis computed tomography angiography or ultrasound scans of the arteries.
• Result: this combined outcome occurred in 8 of 29 people on irbesartan (27.6%) and 15 of 28 on placebo (53.6%); hazard ratio 0.42 (95% confidence interval 0.17 to 0.99). The risk of repeated artery events was also lower with irbesartan (risk ratio 0.37).
• Blood pressure: irbesartan lowered systolic blood pressure by 5.4 mm Hg more than placebo, but the drop was not related to the reduction in events.
• Side effects: 11 episodes of low blood pressure were linked to irbesartan, and the dose was lowered in 4 people.

Much of the difference came from lesions found on scans rather than from symptoms, and the trial was small. The U.S. irbesartan label carries a boxed warning for fetal toxicity: when pregnancy is detected, irbesartan is to be stopped as soon as possible, because drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. This matters in a condition where pregnancy already carries a high artery risk; the Pregnancy and Ehlers-Danlos Syndrome page covers that subject.

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Approval Status in the United States and Elsewhere

United States. Celiprolol is not an approved medicine in the United States. A search of the Food and Drug Administration's Drugs@FDA database through openFDA on 8 November 2026 returned no application for celiprolol, and the only celiprolol entry in the agency's National Drug Code directory is a listing of the raw powder as a bulk ingredient, not a finished medicine. The 2017 review, read in full text, states that celiprolol "is not yet approved in the United States for any indication" and that in 2015 the Food and Drug Administration granted it orphan drug status (a designation for medicines for rare diseases) for vascular Ehlers-Danlos syndrome, citing the agency's orphan designation database; that database could not be opened for this page, so the designation is reported here as the review states it.

The 2022 aortic disease guideline of the American College of Cardiology and the American Heart Association, read in full text, states that studies of celiprolol "have suggested a benefit" in vascular Ehlers-Danlos syndrome "but data were considered to be insufficient" for approval by the Food and Drug Administration, and that other beta-blockers are often prescribed in its absence. A 2024 review, also read in full text, states that celiprolol "is still not approved" by the Food and Drug Administration and is therefore not available in the United States for treating this condition. No Food and Drug Administration decision letter on celiprolol was found in the agency's public collection of complete response letters searched for this page, so the details of the agency's decision are not given here.

The new trial for U.S. approval. The ClinicalTrials.gov record NCT05432466, sponsored by the manufacturer, describes the DiSCOVER trial: a phase 3, randomized, double-blind, placebo-controlled study of about 150 people with gene-confirmed vascular Ehlers-Danlos syndrome, assigned two to one to celiprolol or placebo and run largely from home ("decentralized"). Celiprolol is raised from 100 mg once daily to 200 mg twice daily (400 mg a day) by the fourth month. The double-blind period is planned for about 40 months, or until at least 46 disease-related events have occurred. The main outcome is the time to a first artery, heart, bowel or womb rupture or sudden unexplained death. The record, last verified in August 2025, lists the trial as recruiting, with primary completion estimated for March 2029.

Europe and other countries. The 2017 review states that celiprolol is approved in many countries for heart and blood-vessel conditions such as high blood pressure and angina. The published vascular Ehlers-Danlos syndrome experience comes from France, Belgium, Sweden, Italy and Japan, where patients were treated with it. No source read for this page names an approval specifically for vascular Ehlers-Danlos syndrome in any country.

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Side Effects and Safety as Reported

• Fatigue, dizziness and low blood pressure. Fatigue was the side effect reported in the BBEST trial. The 2025 systematic review lists dizziness and low blood pressure across studies, and in Sweden six of 38 people could not reach the full dose because of side effects.
• Overall rate. The 2017 review reports that pooled data from blood-pressure and angina trials found no difference in side effects between celiprolol and placebo, and less dizziness, fatigue and tiredness than atenolol.
• Heart conditions. The 2017 review states that, as with other beta-blockers, celiprolol is not to be used in cardiogenic shock, decompensated heart failure, sick sinus syndrome, second- or third-degree heart block, or severe bradycardia (a very slow heartbeat).
• Lungs. Ordinary beta-blockers can tighten the airways in asthma. In a 1986 study of 34 people with asthma, single doses of celiprolol did not reduce breathing measures and did not block reliever inhalers, unlike propranolol and, to a lesser degree, atenolol. Even so, the 2017 review notes reports of asthma and bronchospasm (airway narrowing) in people taking celiprolol. A 1993 case report described a severe allergic lung inflammation (hypersensitivity pneumonitis) that cleared after celiprolol was stopped and came back when it was given again by mistake.
• Orange and grapefruit juice. In a 2004 study in 10 healthy volunteers, orange juice cut the peak blood level of a 100 mg celiprolol dose by 89% and the total amount absorbed by 83%. In a 2003 study in 12 volunteers, grapefruit juice reduced the total amount to about 13% of normal and the peak level to about 5%. Heart rate and blood pressure did not differ in these young healthy volunteers. The authors considered both interactions likely to be of clinical importance in some patients. The same 2003 study found that the antifungal itraconazole raised celiprolol levels by 80%. The wider subject is covered on the Grapefruit and Drug Interactions page.
• Irbesartan. Where irbesartan is added, its fetal-toxicity boxed warning applies, as described in the irbesartan section above.

In vascular Ehlers-Danlos syndrome, sudden severe pain in the chest, back, belly or side, a sudden severe headache, or signs of internal bleeding are signs that hospitals treat as emergencies, whether or not a person is taking celiprolol. The Swedish, Italian and Japanese reports all recorded serious artery events in people on the drug.

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What Is Not Known

• How big the benefit really is. The only randomized trial of celiprolol itself had 53 people, no placebo and an early stop. The cohorts that followed had no untreated comparison group. The manufacturer's placebo-controlled trial is not expected to finish before 2029.
• Whether the dose matters. The French cohort found better survival at 400 mg a day, while the Japanese cohort found no link between dose and events, and in the Italian cohort most events happened after the maximum dose was reached.
• How it works. The mechanical-stress idea is a reasoned explanation, not a proven one. The two mouse studies disagree with each other about celiprolol and about losartan.
• Whether other beta-blockers work as well. The 2022 United States guideline notes that other beta-blockers are often prescribed where celiprolol is unavailable; the studies on this page do not compare them with celiprolol in this disease.
• People without a confirmed gene change. The BBEST authors stated that this "remains to be established."
• Pregnancy and children. None of the trial and cohort abstracts read for this page report results for celiprolol in pregnancy or in children.
• Combination treatment over the long term. The irbesartan trial lasted 2 years in 57 people. Whether the benefit lasts, and how it compares with other angiotensin II receptor blockers, has not been tested in a trial.

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Key Research Papers

1. Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, et al. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010;376(9751):1476-84. Erratum: Lancet. 2016;388(10044):564. PubMed PMID: 20825986
2. Frank M, Adham S, Seigle S, Legrand A, Mirault T, Henneton P, et al. Vascular Ehlers-Danlos Syndrome: Long-Term Observational Study. J Am Coll Cardiol. 2019;73(15):1948-1957. PubMed PMID: 30999998
3. Jeunemaitre X, Mousseaux E, Frank M, Adham S, Pitocco F, Billon C, et al. Efficacy of Irbesartan in Celiprolol-Treated Patients With Vascular Ehlers-Danlos Syndrome. Circulation. 2025;151(10):686-695. PubMed PMID: 39906986
4. Baderkhan H, Wanhainen A, Stenborg A, Stattin EL, Björck M. Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome. Eur J Vasc Endovasc Surg. 2021;61(2):326-331. PubMed PMID: 33223285
5. Buso G, Paini A, Agabiti-Rosei C, De Ciuceis C, Bertacchini F, Stassaldi D, et al. Despite celiprolol therapy, patients with vascular Ehlers-Danlos syndrome remain at risk of vascular events: A 12-year experience in an Italian referral center. Vasc Med. 2024;29(3):265-273. PubMed PMID: 38102934
6. Furuhata-Yoshimura M, Yamaguchi T, Kosho T. Clinical Outcomes and Patient Experiences With Celiprolol Therapy in Vascular Ehlers-Danlos Syndrome: The First Non-European Cohort. Am J Med Genet A. 2026;200(10):2241-2249. PubMed PMID: 42124361
7. Bowen JM, Hernandez M, Johnson DS, Green C, Kammin T, Baker D, et al. Diagnosis and management of vascular Ehlers-Danlos syndrome: Experience of the UK national diagnostic service, Sheffield. Eur J Hum Genet. 2023;31(7):749-760. PubMed PMID: 36977837
8. Saputra PBT, Widiarti W, Siahaan PP, Putra RM, Putranto JNE, Budiarto RM, et al. The Impact of Celiprolol in Vascular Ehlers-Danlos Syndrome: A Systematic Review of Current Evidence. Med Sci (Basel). 2025;13(2):74. PubMed PMID: 40559232
9. Buso G, Corvini F, Fusco EM, Messina M, Cherubini F, Laera N, et al. Current Evidence and Future Perspectives in the Medical Management of Vascular Ehlers-Danlos Syndrome: Focus on Vascular Prevention. J Clin Med. 2024;13(14):4255. PubMed PMID: 39064294
10. Isselbacher EM, Preventza O, Hamilton Black J 3rd, Augoustides JG, Beck AW, Bolen MA, et al. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2022;146(24):e334-e482. PubMed PMID: 36322642
11. Dubacher N, Münger J, Gorosabel MC, Crabb J, Ksiazek AA, Caspar SM, et al. Celiprolol but not losartan improves the biomechanical integrity of the aorta in a mouse model of vascular Ehlers-Danlos syndrome. Cardiovasc Res. 2020;116(2):457-465. PubMed PMID: 31056650
12. Legrand A, Guery C, Faugeroux J, Fontaine E, Beugnon C, Gianfermi A, et al. Comparative therapeutic strategies for preventing aortic rupture in a mouse model of vascular Ehlers-Danlos syndrome. PLoS Genet. 2022;18(3):e1010059. PubMed PMID: 35245290
13. Nawarskas JJ, Cheng-Lai A, Frishman WH. Celiprolol: A Unique Selective Adrenoceptor Modulator. Cardiol Rev. 2017;25(5):247-253. PubMed PMID: 28742547
14. Riddell JG, Shanks RG, Brogden RN. Celiprolol. A preliminary review of its pharmacodynamic and pharmacokinetic properties and its therapeutic use in hypertension and angina pectoris. Drugs. 1987;34(4):438-58. PubMed PMID: 2890513
15. Milne RJ, Buckley MM. Celiprolol. An updated review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in cardiovascular disease. Drugs. 1991;41(6):941-69. PubMed PMID: 1715268
16. Wheeldon NM, McDevitt DG, Lipworth BJ. Selectivity of antagonist and partial agonist activity of celiprolol in normal subjects. Br J Clin Pharmacol. 1992;34(4):337-43. PubMed PMID: 1333781
17. Witchitz S, Cohen-Solal A, Dartois N, Weisslinger N, Juste K, Darmon JY. Treatment of heart failure with celiprolol, a cardioselective beta blocker with beta-2 agonist vasodilatory properties. The CELICARD Group. Am J Cardiol. 2000;85(12):1467-71. PubMed PMID: 10856394
18. Doshan HD, Rosenthal RR, Brown R, Slutsky A, Applin WJ, Caruso FS. Celiprolol, atenolol and propranolol: a comparison of pulmonary effects in asthmatic patients. J Cardiovasc Pharmacol. 1986;8 Suppl 4:S105-8. PubMed PMID: 2427836
19. Lombard JN, Bonnotte B, Maynadie M, Foucher P, Reybet Degat O, Jeannin L, et al. Celiprolol pneumonitis. Eur Respir J. 1993;6(4):588-91. PubMed PMID: 8098286
20. Lilja JJ, Juntti-Patinen L, Neuvonen PJ. Orange juice substantially reduces the bioavailability of the beta-adrenergic-blocking agent celiprolol. Clin Pharmacol Ther. 2004;75(3):184-90. PubMed PMID: 15001969
21. Lilja JJ, Backman JT, Laitila J, Luurila H, Neuvonen PJ. Itraconazole increases but grapefruit juice greatly decreases plasma concentrations of celiprolol. Clin Pharmacol Ther. 2003;73(3):192-8. PubMed PMID: 12621384

Regulatory and Trial Records

1. U.S. National Library of Medicine. DailyMed / openFDA: irbesartan tablets prescribing information, boxed warning "Fetal Toxicity". DailyMed: irbesartan labels
2. ClinicalTrials.gov. A Phase 3 Randomized, Double-Blind, Decentralized Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in the Treatment of Patients With COL3A1-Positive Vascular Ehlers-Danlos Syndrome (DiSCOVER). NCT05432466
3. ClinicalTrials.gov. Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type (BBEST). NCT00190411
4. ClinicalTrials.gov. Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE). NCT02597361

PubMed Topic Searches

1. PubMed: celiprolol in vascular Ehlers-Danlos syndrome
2. PubMed: celiprolol pharmacology
3. PubMed: celiprolol in high blood pressure
4. PubMed: angiotensin II receptor blockers in vascular Ehlers-Danlos syndrome

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Connections

• Drugs — the drug pages on this site
• Classical and Vascular Ehlers-Danlos Syndrome — the condition celiprolol was tested in
• Pregnancy and Ehlers-Danlos Syndrome — artery risk in pregnancy
• Ehlers-Danlos Syndrome — all types
• Aortic Dissection — the event the trials counted
• Aortic Aneurysm — widened and weakened arteries
• Marfan Syndrome — another inherited artery disease
• Loeys-Dietz Syndrome — a related inherited aortic disease
• Hypertension — celiprolol's original use
• Grapefruit and Drug Interactions — juices that lower celiprolol absorption

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