Botulinum toxin type A

Identification

Summary

Botulinum toxin type A is a purified form of botulinum toxin type A used to block acetylcholine release in the treatment of chronic sialorrhea, muscle spasticity, and dystonia, as well as in cosmetic applications.

Brand Names

Botox, Botox Cosmetic, Dysport, Xeomin

Generic Name

Botulinum toxin type A

DrugBank Accession Number

DB00083

Background

In 2002, botulinum toxin A, also known as onabotulinumtoxinA or Botox, was the first type A botulism toxin to be introduced into the market for cosmetic use.⁸ With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic imperfections, muscle spasms, and other conditions.^7,20 A popular use for Botox is the treatment of facial wrinkles and lines, however, there are many uses for the botulinum toxin A in the treatment of dystonia, incontinence, migraine, blepharospasm, and hyperhidrosis.^15,19

Type

Biotech

Groups

Approved, Investigational

Biologic Classification

Protein Based Therapies
Other protein based therapies

Protein Structure

Protein Chemical Formula: C₆₇₆₀H₁₀₄₄₇N₁₇₄₃O₂₀₁₀S₃₂
Protein Average Weight: 900000.0 Da

Sequences

>Botulinum Toxin Type A Sequence
MPFVNKQFNYKDPVNGVDIAYIKIPNVGQMQPVKAFKIHNKIWVIPERDTFTNPEEGDLN
PPPEAKQVPVSYYDSTYLSTDNEKDNYLKGVTKLFERIYSTDLGRMLLTSIVRGIPFWGG
STIDTELKVIDTNCINVIQPDGSYRSEELNLVIIGPSADIIQFECKSFGHEVLNLTRNGY
GSTQYIRFSPDFTFGFEESLEVDTNPLLGAGKFATDPAVTLAHELIHAGHRLYGIAINPN
RVFKVNTNAYYEMSGLEVSFEELRTFGGHDAKFIDSLQENEFRLYYYNKFKDIASTLNKA
KSIVGTTASLQYMKNVFKEKYLLSEDTSGKFSVDKLKFDKLYKMLTEIYTEDNFVKFFKV
LNRKTYLNFDKAVFKINIVPKVNYTIYDGFNLRNTNLAANFNGQNTEINNMNFTKLKNFT
GLFEFYKLLCVRGIITSKTKSLDKGYNKALNDLCIKVNNWDLFFSPSEDNFTNDLNKGEE
ITSDTNIEAAEENISLDLIQQYYLTFNFDNEPENISIENLSSDIIGQLELMPNIERFPNG
KKYELDKYTMFHYLRAQEFEHGKSRIALTNSVNEALLNPSRVYTFFSSDYVKKVNKATEA
AMFLGWVEQLVYDFTDETSEVSTTDKIADITIIIPYIGPALNIGNMLYKDDFVGALIFSG
AVILLEFIPEIAIPVLGTFALVSYIANKVLTVQTIDNALSKRNEKWDEVYKYIVTNWLAK
VNTQIDLIRKKMKEALENQAEATKAIINYQYNQYTEEEKNNINFNIDDLSSKLNESINKA
MININKFLNQCSVSYLMNSMIPYGVKRLEDFDASLKDALLKYIYDNRGTLIGQVDRLKDK
VNNTLSTDIPFQLSKYVDNQRLLSTFTEYIKNIINTSILNLRYESNHLIDLSRYASKINI
GSKVNFDPIDKNQIQLFNLESSKIEVILKNAIVYNSMYENFSTSFWIRIPKYFNSISLNN
EYTIINCMENNSGWKVSLNYGEIIWTLQDTQEIKQRVVFKYSQMINISDYINRWIFVTIT
NNRLNNSKIYINGRLIDQKPISNLGNIHASNNIMFKLDGCRDTHRYIWIKYFNLFDKELN
EKEIKDLYDNQSNSGILKDFWGDYLQYDKPYYMLNLYDPNKYVDVNNVGIRGYMYLKGPR
GSVMTTNIYLNSSLYRGTKFIIKKYASGNKDNIVRNNDRVYINVVVKNKEYRLATNASQA
GVEKILSALEIPDVGNLSQVVVMKSKNDQGITNKCKMNLQDNNGNDIGFIGFHQFNNIAK
LVASNWYNRQIERSSRTLGCSWEFIPVDDGWGERPL

Download FASTA Format

Synonyms

AbobotulinumtoxinA
Botulinum A neurotoxin
Botulinum antitoxin type A
Botulinum toxin A
Botulinum toxin type A
BTX-A
EvabotulinumtoxinA
IncobotulinumtoxinA
OnabotulinumtoxinA
Prabotulinumtoxin A
Toxina botulínica A
Toxine botulinique A

External IDs

AGN 191622
ANT-1207
ANT-1401
ANT-1403
CNT 52120
NT 201

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Pharmacology

Indication

Botulinum toxin A is indicated for a variety of conditions, depending on the preparations. Cosmetically, it is used for the treatment of facial fine lines and wrinkles, specifically for upper facial rhytides, including forehead, lateral canthus, and glabellar lines.¹⁹

In addition to the above indications, botulinum toxin A is used for the following conditions: treatment of adults with symptomatic overactive bladder with or without incontinence, treatment of incontinence in adult patients who are not candidates for anticholinergic therapy, treatment of Neurogenic Detrusor Overactivity (NDO) in patients over 5 years who cannot undergo anticholinergic therapy. Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus,¹⁵ and disorders of the 7th cranial nerve.²⁰

Off-label, botulinum toxin A is used for a variety of conditions such as temporomandibular joint (TMJ) disorders and myofascial pain¹², neurogenic thoracic outlet syndrome, epicondylitis, post-stroke pain, post-herpetic neuralgia, diabetic neuropathy, trigeminal neuralgia, neuropathic pain, spinal cord injury, and bladder pain.¹³

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Associated Conditions

Indication Type	Indication	Approval Level	Age Group	Patient Characteristics	Dose Form
Treatment of	Bladder pain	••• •••••			•••••••••• ••••••• •••••••••••• ••• ••••••••
Treatment of	Blepharospasm	••••••••••••	•••••	•••••••••• ••••••• •••• •••••••••••••••••• •••••••	•••••••••• ••••••• ••• ••••••••
Management of	Blepharospasm	••••••••••••			•••••••••• ••••••••
Management of	Cervical dystonia	••••••••••••	•••••		•••••••••• ••••••••
Prophylaxis of	Chronic migraine	••••••••••••	•••••		•••••••••• ••••••••

Contraindications & Blackbox Warnings

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Pharmacodynamics

Botulinum toxin A inhibits the release of acetylcholine, relieving muscle contraction and spasm associated with many conditions, such as incontinence and dystonia. Cosmetically, botulinum toxin A paralyses muscles in the face to temporarily treat wrinkles.^9,19 The maximum effects of muscle paralysis occur four to seven days after a dose.⁶ When injected at therapeutic doses, botulinum toxin A causes partial chemical denervation of muscle tissue, causing local reduction of muscle activity. Muscle atrophy may result, axonal sprouting may begin, and extrajunctional acetylcholine receptors can be formed. Reinnervation of the muscle may occur, reversing muscle denervation caused by botulinum toxin A.¹⁵

Mechanism of action

Botulinum toxin is a 150-kDa molecular weight protein consisting of a light chain (50 kDa) and heavy chain (100 kDa) linked by a single disulfide bond. The crystal structure reveals 3 lobes - the light chain, the amino-terminal portion of the heavy chain, and the carboxyl-terminal portion of the heavy chain.¹¹

Botulinum toxin type A blocks neuromuscular transmission on motor or sympathetic nerve terminals, inhibiting the release of acetylcholine.¹⁵ Botulinum toxins have actions on various regions: the neuromuscular junction, autonomic ganglia, and both postganglionic sympathetic and parasympathetic nerve endings. The heavy chain of the toxin binds selectively at the presynaptic surface of cholinergic neurons in an irreversible fashion. After binding, the toxin-receptor complex is transported into the cell by endocytosis. The disulfide bond between the two chains is cleaved and the botulism toxin enters the cytoplasm. The light chain specifically interacts with SNAP-25 in the nerve terminals to block binding of acetylcholine vesicles with the cell membrane. SNAP-25 is required for successful binding and release of acetylcholine from vesicles in nerve endings.⁶

Target	Actions	Organism
ASynaptosomal-associated protein 25	inhibitor	Humans
URho-related GTP-binding protein RhoB	inhibitor	Humans

Absorption

The chemical complexity of botulinum toxin type A combined with its extreme potency limits the opportunity to study its pharmacokinetic profile in humans.¹⁵ For this reason, human pharmacokinetic studies have not been performed. Animal studies using radio labeled botulinum toxin suggest it is absorbed systemically after subcutaneous and intranasal administration. Clinical relevance is unknown.¹¹

Volume of distribution

There are extremely limited data about the pharmacokinetics of botulinum toxin in humans.¹⁵ An animal study demonstrated that botulinum toxin accumulates in the liver and spleen in rats and mice when injected subcutaneously or administered intranasally.¹¹

Protein binding

A pharmacokinetic study in mice and rats revealed significant binding to albumin after subcutaneous injection or intranasal administration.¹¹

Metabolism

Metabolism information for botulinum A toxin is not readily available in the literature.^11,15

Route of elimination

Elimination information for botulinum A toxin is not readily available in the literature.^11,15

Half-life

There is no readily available data about the pharmacokinetics of botulinum toxin in humans.¹⁵ The elimination half-life for non-metabolized botulinum toxin in blood and serum ranged from 230 to 260 min in a pharmacokinetic study of rats and mice.¹¹

Clearance

Clearance information for botulinum A toxin is not readily available in the literature.^11,15

Adverse Effects

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Toxicity

The intraperitoneal LD50 of botulinum toxin A in mice is 160 ng/kg.²² An overdose of botulinum toxin A is expected to produce neuromuscular weakness, manifested by a variety of symptoms that may not appear immediately after injection. Dysphagia, dysphonia, weakness, dyspnea or respiratory distress may indicate distant spread of botulinum toxin A effects.¹⁴ If an overdose is suspected or confirmed, patients should be monitored for several weeks closely for local and distant neurologic effects. Hospitalization or further medical evaluation and appropriate intervention should be provided immediately.¹⁵

Pathways

Not Available

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Not Available

Interactions

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This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

Drug	Interaction
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1,2-Benzodiazepine	The risk or severity of CNS depression can be increased when Botulinum toxin type A is combined with 1,2-Benzodiazepine.
Acetazolamide	The risk or severity of CNS depression can be increased when Botulinum toxin type A is combined with Acetazolamide.
Acetophenazine	The risk or severity of CNS depression can be increased when Botulinum toxin type A is combined with Acetophenazine.
Acetyldigitoxin	The risk or severity of Cardiac Arrhythmia can be increased when Botulinum toxin type A is combined with Acetyldigitoxin.
Aclidinium	The risk or severity of adverse effects can be increased when Aclidinium is combined with Botulinum toxin type A.

Food Interactions

No interactions found.

Products

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Botox	Powder, for solution	200 unit / vial	Intramuscular	Abbvie	2023-10-11	Not applicable
Botox	Powder, for solution	50 unit / vial	Intramuscular	Abbvie	2023-06-20	Not applicable
Botox	Powder, for solution	100 unit / vial	Intramuscular	Abbvie	1992-12-31	Not applicable
BOTOX Cosmetic	Powder, for solution	100 unit / vial	Intramuscular	Abbvie	2001-05-07	Not applicable
BOTOX Cosmetic	Powder, for solution	50 unit / vial	Intramuscular	Abbvie	Not applicable	Not applicable

Chemical Identifiers

UNII: 0A6JH35GMQ
CAS number: 93384-43-1

References

Synthesis Reference

Alexander Zabudkin, Jun Krasnopolsky, Aleksandr Itkin, Dmitry Itkin.(2003). Pharmaceutical preparation of botulinum neurotoxin, methods of synthesis and methods of clinical use (US). Patent number WO2003101483A1.

General References

Montecucco C, Molgo J: Botulinal neurotoxins: revival of an old killer. Curr Opin Pharmacol. 2005 Jun;5(3):274-9. [Article]
Brin MF, Lew MF, Adler CH, Comella CL, Factor SA, Jankovic J, O'Brien C, Murray JJ, Wallace JD, Willmer-Hulme A, Koller M: Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999 Oct 22;53(7):1431-8. [Article]
Shukla HD, Sharma SK: Clostridium botulinum: a bug with beauty and weapon. Crit Rev Microbiol. 2005;31(1):11-8. [Article]
Eisenach JH, Atkinson JL, Fealey RD: Hyperhidrosis: evolving therapies for a well-established phenomenon. Mayo Clin Proc. 2005 May;80(5):657-66. [Article]
Schurch B, Corcos J: Botulinum toxin injections for paediatric incontinence. Curr Opin Urol. 2005 Jul;15(4):264-7. [Article]
Nigam PK, Nigam A: Botulinum toxin. Indian J Dermatol. 2010;55(1):8-14. doi: 10.4103/0019-5154.60343. [Article]
Naumann M, Jankovic J: Safety of botulinum toxin type A: a systematic review and meta-analysis. Curr Med Res Opin. 2004 Jul;20(7):981-90. doi: 10.1185/030079904125003962. [Article]
Lorenc ZP, Kenkel JM, Fagien S, Hirmand H, Nestor MS, Sclafani AP, Sykes JM, Waldorf HA: A review of onabotulinumtoxinA (Botox). Aesthet Surg J. 2013 Mar;33(1 Suppl):9S-12S. doi: 10.1177/1090820X12474629. [Article]
Satriyasa BK: Botulinum toxin (Botox) A for reducing the appearance of facial wrinkles: a literature review of clinical use and pharmacological aspect. Clin Cosmet Investig Dermatol. 2019 Apr 10;12:223-228. doi: 10.2147/CCID.S202919. eCollection 2019. [Article]
Lu B: The destructive effect of botulinum neurotoxins on the SNARE protein: SNAP-25 and synaptic membrane fusion. PeerJ. 2015 Jun 30;3:e1065. doi: 10.7717/peerj.1065. eCollection 2015. [Article]
Ravichandran E, Gong Y, Al Saleem FH, Ancharski DM, Joshi SG, Simpson LL: An initial assessment of the systemic pharmacokinetics of botulinum toxin. J Pharmacol Exp Ther. 2006 Sep;318(3):1343-51. doi: 10.1124/jpet.106.104661. Epub 2006 Jun 16. [Article]
Mor N, Tang C, Blitzer A: Temporomandibular Myofacial Pain Treated with Botulinum Toxin Injection. Toxins (Basel). 2015 Jul 24;7(8):2791-800. doi: 10.3390/toxins7082791. [Article]
Padda IS, Tadi P: Botulinum Toxin . [Article]
Omprakash Hm, Rajendran Sc: Botulinum Toxin Deaths: What is the Fact? J Cutan Aesthet Surg. 2008 Jul;1(2):95-7. doi: 10.4103/0974-2077.44169. [Article]
FDA Approved Products: Botox (onabotulinumtoxinA) for injection [Link]
World Health Organization: Botulism [Link]
Allergan MSDS: Botox [Link]
DermNet NZ: Botulinum toxin [Link]
Product monograph: Botox Cosmetic (botulinum toxin A) for injection [Link]
Product Monograph: Botox (Clostridium botulinum type A neurotoxin complex ) powder for injectable solution [Link]
FDA Approved Drug Products: XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use [Link]
Allergan MSDS: OnabotulinumtoxinA [Link]

External Links

UniProt: P10845
Genbank: X52066
KEGG Drug: D00783
KEGG Compound: C07946
PubChem Substance: 46505347
RxNav: 1000104
Therapeutic Targets Database: DAP001298
PharmGKB: PA164754825
RxList: RxList Drug Page
Wikipedia: Botulinum_toxin

FDA label

Download (115 KB)

Clinical Trials

Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">

Phase	Status	Purpose	Conditions	Count
4	Active Not Recruiting	Basic Science	Migraine	1
4	Active Not Recruiting	Prevention	Keloids Scars	1
4	Active Not Recruiting	Treatment	Facial Skin Wrinkles / Loss of Volume and Skin Quality / Skin Folds	1
4	Active Not Recruiting	Treatment	Glabellar Frown Lines (GL)	1
4	Active Not Recruiting	Treatment	Increased frequency of urination / Overactive Bladder Syndrome (OABS) / Urinary Urge Incontinence / Urinary Urgency	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Allergan Inc.
Tercica Inc.

Dosage Forms

Form	Route	Strength
Injection, powder, for solution	Intramuscular	125 U
Injection, powder, for solution	Intramuscular
Injection, powder, for solution		100 IU
Powder	Intramuscular	100 unit/1vial
Powder, for solution	Intramuscular	100 unit / vial
Powder, for solution	Intramuscular	200 unit / vial
Injection, powder, for solution	Intramuscular	100 U
Injection	Intramuscular	100 U
Injection, powder, for solution	Intradermal; Intramuscular	100 units
Injection, powder, for solution	Intradermal; Intramuscular; Subcutaneous	200 Units
Injection, powder, for solution	Intradermal; Intramuscular; Subcutaneous	50 Units/vial
Injection, powder, for solution	Intradermal; Intramuscular	200 U
Solution	Intramuscular	100 UI
Injection, powder, for solution	Intramuscular	500 unit/1vial
Injection, powder, for solution	Intramuscular; Subcutaneous	300 U
Injection, powder, for solution	Intramuscular; Subcutaneous	500 UI
Injection, powder, lyophilized, for solution	Intramuscular	300 [USP'U]/1
Solution	Intramuscular	500.000 U
Injection, powder, for solution		300 unit/1vial
Injection, powder, lyophilized, for solution	Intramuscular; Subcutaneous	300 U
Injection, solution	Intramuscular	500 U
Powder, for solution	Intramuscular	300 unit / vial
Powder, for solution	Intramuscular	500 unit / vial
Injection, powder, lyophilized, for solution	Intramuscular; Subcutaneous	500 U
Powder	Intramuscular	200 unit/1vial
Powder	Intramuscular	50 unit/1vial
Injection, powder, for solution
Solution	Intramuscular	100 U
Injection, powder, lyophilized, for solution	Intramuscular; Subcutaneous	50 U
Injection, powder, lyophilized, for solution	Intramuscular; Subcutaneous	100 IU
Injection, powder, lyophilized, for solution	Intramuscular	200 IU
Injection, powder, for solution	Intramuscular	50 U
Injection, powder, for solution	Parenteral	4 AU/ 0.1 ml
Injection, powder, for solution	Parenteral	4 AU/0.1ml
Solution	Parenteral	50.000 U
Injection, powder, for solution		50 IU
Injection, powder, for solution	Parenteral	100 U
Injection, powder, for solution	Parenteral	200 U
Injection, powder, for solution	Parenteral	50 U
Powder, for solution	Intramuscular	50 unit / vial
Injection, powder, for solution		50 LD50 Units
Injection, powder, for solution	Intramuscular	100 LD50 units
Injection, powder, for solution	Intramuscular	50 LD50 units
Injection, powder, lyophilized, for solution	Intramuscular	100 U
Injection, powder, lyophilized, for solution	Intramuscular	50 U
Injection, powder, for solution		100 unit/1vial
Injection, powder, lyophilized, for solution		100 unit/1vial
Injection, powder, for solution		50 unit/1vial

Prices

Unit description	Cost	Unit
Botox 200 unit vial	1260.0USD	vial
Dysport 500 unit vial	852.0USD	vial
Botox 100 unit	655.2USD	vial
Botox 100 unit vial	630.0USD	vial
Botox cosmetic 100 unit vial	630.0USD	vial
Botox cosmetic 50 unit vial	346.8USD	vial
Botox (100 - 200 unit/Vial)	3.74USD	vial

DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)	Region
CA2280565	No	2005-11-15	2019-08-20
CA2310845	No	2001-05-15	2014-06-07

Properties

State

Solid

Experimental Properties

Property	Value	Source
melting point (°C)	85.5-86.5	https://www.guidechem.com/dictionary_keys_Botox-p1.html
water solubility	>10 mg/ml	http://www.t3db.ca/toxins/T3D3127
isoelectric point	5.6	https://mmbr.asm.org/content/mmbr/56/1/80.full.pdf

Targets

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Details1. Synaptosomal-associated protein 25

Kind: Protein
Organism: Humans
Pharmacological action: Yes
Actions: Inhibitor

General Function: Syntaxin-1 binding
Specific Function: t-SNARE involved in the molecular regulation of neurotransmitter release. May play an important role in the synaptic function of specific neuronal systems. Associates with proteins involved in vesi...
Gene Name: SNAP25
Uniprot ID: P60880
Uniprot Name: Synaptosomal-associated protein 25
Molecular Weight: 23314.905 Da

References

Zhou JY, Wang ZF, Ren XM, Tang MZ, Shi YL: Antagonism of botulinum toxin type A-induced cleavage of SNAP-25 in rat cerebral synaptosome by toosendanin. FEBS Lett. 2003 Dec 4;555(2):375-9. [Article]
Flynn TC: Myobloc. Dermatol Clin. 2004 Apr;22(2):207-11, vii. [Article]
Straughan D: Progress in applying the Three Rs to the potency testing of Botulinum toxin type A. Altern Lab Anim. 2006 Jun;34(3):305-13. [Article]
Vaidyanathan VV, Yoshino K, Jahnz M, Dorries C, Bade S, Nauenburg S, Niemann H, Binz T: Proteolysis of SNAP-25 isoforms by botulinum neurotoxin types A, C, and E: domains and amino acid residues controlling the formation of enzyme-substrate complexes and cleavage. J Neurochem. 1999 Jan;72(1):327-37. doi: 10.1046/j.1471-4159.1999.0720327.x. [Article]
FDA Approved Products: Botox (onabotulinumtoxinA) for injection [Link]

Details2. Rho-related GTP-binding protein RhoB

Kind: Protein
Organism: Humans
Pharmacological action: Unknown
Actions: Inhibitor

General Function: Gtpase activity
Specific Function: Mediates apoptosis in neoplastically transformed cells after DNA damage. Not essential for development but affects cell adhesion and growth factor signaling in transformed cells. Plays a negative r...
Gene Name: RHOB
Uniprot ID: P62745
Uniprot Name: Rho-related GTP-binding protein RhoB
Molecular Weight: 22123.185 Da

References

Ishida H, Zhang X, Erickson K, Ray P: Botulinum toxin type A targets RhoB to inhibit lysophosphatidic acid-stimulated actin reorganization and acetylcholine release in nerve growth factor-treated PC12 cells. J Pharmacol Exp Ther. 2004 Sep;310(3):881-9. Epub 2004 May 12. [Article]

Carriers

Details1. Serum albumin

Kind: Protein
Organism: Humans
Pharmacological action: Unknown
Actions: Binder

General Function: Toxic substance binding
Specific Function: Serum albumin, the main protein of plasma, has a good binding capacity for water, Ca(2+), Na(+), K(+), fatty acids, hormones, bilirubin and drugs. Its main function is the regulation of the colloid...
Gene Name: ALB
Uniprot ID: P02768
Uniprot Name: Serum albumin
Molecular Weight: 69365.94 Da

References

Ravichandran E, Gong Y, Al Saleem FH, Ancharski DM, Joshi SG, Simpson LL: An initial assessment of the systemic pharmacokinetics of botulinum toxin. J Pharmacol Exp Ther. 2006 Sep;318(3):1343-51. doi: 10.1124/jpet.106.104661. Epub 2006 Jun 16. [Article]

Drug created at June 13, 2005 13:24 / Updated at January 02, 2024 23:41

Botulinum toxin type A

Identification

Pharmacology

Interactions

Products

Categories

Chemical Identifiers

References

Clinical Trials

Pharmacoeconomics

Properties

Targets

References

References

Carriers

References