acebutolol

Trade name: sectral

Small moleculeapproved

Approved

Dec 28, 1984

Acebutolol is a cardioselective, beta-adrenoreceptor blocking agent, which possesses mild intrinsic sympathomimetic activity (ISA) in its therapeutically effective dose range. Acebutolol is marketed under the trade names Sectral, Prent. Acebutolol is indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Acebutolol is also indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats. Acebutolol is a selective β1-receptor antagonist. Activation of β1-receptors by epinephrine increases the heart rate and the blood pressure, and the heart consumes more oxygen. Acebutolol blocks these receptors, lowering the heart rate and blood pressure. This drug then has the reverse effect of epinephrine. In addition, beta blockers prevent the release of renin, which is a hormone produced by the kidneys which leads to constriction of blood vessels. — NCATS

Clinical trial activity

3 trials · 6 clinical orgs · 7 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Aug 1, 1985 (NCT00000522)

Timeline

1980s

Dec 28, 1984
Earliest FDA Approval
Dec 28, 1984
Dr. Reddy's Laboratories — NDA Secondary Org
Jan 1, 1985
Earliest Phase 2 Sponsor(trial)

1990s

Apr 24, 1995
Mylan — Marketing Organization
Apr 24, 1995
PHARMOBEDIENT — Marketing Organization
Oct 18, 1995
Watson Pharmaceuticals — Marketing Organization
Oct 18, 1995
Ani Pharmaceuticals — Marketing Organization
Dec 30, 1999
Amneal Pharmaceuticals — Marketing Organization

2010s

Jan 1, 2012
Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Beta-1 adrenergic receptorANTAGONIST
ADRB1 antagonist
- Beta-1 adrenergic receptor (ADRB1) ↗

Approval history

approvedDec 28, 1984

Chemistry & pharmacology

Loading structure…

SMILES

CCCC(=O)Nc1ccc(OCC(O)CNC(C)C)c(C(C)=O)c1

Mol. weight: 336.43 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)butyranilide
3'-acetyl-4'-(2-hydroxy-3-(isopropylamino)propoxy)butyranilide
5'-butyramido-2'-(2-hydroxy-3-isopropylaminopropoxy)acetophenone
5'-butyramido-2'-(2-hydroxy-3-isopropylaminopropoxy)acetophenone
acebut hcl
acebutolol
acebutolol
acebutolol
acebutolol
acebutolol
acebutolol
acebutolol
acebutolol
(+/-)-acebutolol
(±)-acebutolol
(±)-acebutolol
acebutolol hcl
acebutolol hcl
acebutolol hcl
acebutolol hydrochloride
acebutolol hydrochloride
acebutolol hydrochloride
acebutolol hydrochloride
acebutololum
acebutololum
acetobutolol
acetobutolol
dl-acebutolol
il-17803a
il-17803a
il-17803a
il-17803a
il-17803a
il-17803a
m&b-17803a
m&b-17803a
n-[3-acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]butanamide
n-[3-acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]butanamide
n-(3-acetyl-4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl)butanamide
n-(3-acetyl-4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl)butanamide
(rs)-acebutolol
sectral
sectral
sectral
sectral 200
sectral 400

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT01743885	Phase 3	Nov 1, 2012	University of Montpellier
NCT01514019	Phase 4	Jan 1, 2012	Kyushu University, Oita University, Seoul National University
NCT00000522	Phase 2	Aug 1, 1985	National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota

Showing 3 of 3 trials

Page 1 / 1

Organizations

Research & Development (6)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Kyushu University	Academic/Hospital	1	0	1	2012
National Heart, Lung, and Blood Institute (NHLBI)	Government	1	0	1	1985
Oita University	Academic/Hospital	1	0	1	2012
Seoul National University	Academic/Hospital	1	1	1	2012
University of Minnesota	Academic/Hospital	1	1	1	1985
University of Montpellier	Academic/Hospital	1	1	1	2012

6 organizations

Page 1 / 1

Marketing (8)

Organization	Org type	Relationship	Date
American Home Products	For profit	NDA	—
Amneal Pharmaceuticals	For profit	MKTG	Dec 30, 1999
Ani Pharmaceuticals	For profit	SYN	Oct 18, 1995
Ani Pharmaceuticals	For profit	MKTG	Oct 18, 1995
Dr. Reddy's Laboratories	For profit	NDA2	Dec 28, 1984
Mylan	For profit	MKTG	Apr 24, 1995
PHARMOBEDIENT	For profit	MKTG	Apr 24, 1995
Watson Pharmaceuticals	For profit	MKTG	Oct 18, 1995