bitolterol

Trade name: tornalate

Small moleculeapproved

Approved

Dec 28, 1984

Bitolterol is a beta 2-adrenergic agonist. Since it in itself is biologically inactive, bitolterol is considered a pro-drug. When administered it is activated within the lung by esterase hydrolysis to the active compound colterol catecholamine N-t-butyl-arterenol. Bitolterol was marked under the name tornalate and was indicated to prevent and treat of reversible bronchospasm associated with asthma or chronic obstructive pulmonary diseases. But that drug was withdrawn from the market by Elan Pharmaceuticals in 2001. — NCATS

Clinical trial activity

0 trials · 0 clinical orgs · 1 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Timeline

1980s

Dec 28, 1984
Sanofi-Aventis — Earliest FDA Approval
Dec 28, 1984
Sanofi-Aventis — NDA Organization
Dec 28, 1984
Sanofi-Aventis — NDA Secondary Org

Indications

Approved for

Mechanism of action

Beta-2 adrenergic receptorAGONIST
ADRB2 agonist
- Beta-2 adrenergic receptor (ADRB2) ↗

Approval history

approvedDec 28, 1984

Chemistry & pharmacology

Loading structure…

SMILES

Cc1ccc(C(=O)Oc2ccc(C(O)CNC(C)(C)C)cc2OC(=O)c2ccc(C)cc2)cc1

Mol. weight: 461.56 g/mol
Lipinski Ro5: 1 violation(s)
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Topical
Availability: Discontinued

Oral

Parenteral

Topical

Yes

Prodrug

Sources

Also known as

bitolterol
bitolterol
bitolterol
bitolterol
bitolterol
bitolterol
bitolterol
bitolterol
bitolterol mesilate
bitolterol mesilate
bitolterol mesilate
bitolterol mesylate
bitolterol mesylate
bitolterol mesylate
bitolterol mesylate
bitolterol mesylate
bitolterol mesylate
bitolterol methanesulfonate
bitolterol methanesulfonate
bitolterol methanesulfonate
bitolterol methanesulfonate
bitolterol methanesulfonate
bitolterol methanesulfonate
bitolterolum
bitolterolum
dura brand of bitolterol methanesulfonate
s-1540
tomalate
tornalate
tornalate
tornalate
tornalate
tornalate
win 32784
win-32784
win-32784

Organizations

Marketing (2)

Organization	Org type	Relationship	Date
Sanofi-Aventis	For profit	NDA	Dec 28, 1984
Sanofi-Aventis	For profit	NDA2	Dec 28, 1984