Last update 11 Jul 2024

Migalastat Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
1-Deoxygalactonojirimycin, 1-Deoxygalactostatin, Migalastat hydrochloride (JAN/USAN)
+ [10]
Target
Mechanism
GLA stimulants(α-Galactosidase stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (25 May 2016),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (JP), Fast Track (US), Priority Review (US), Accelerated Approval (US)
Login to view First Approval Timeline

Structure

Molecular FormulaC6H13NO4
InChIKeyLXBIFEVIBLOUGU-DPYQTVNSSA-N
CAS Registry108147-54-2
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Fabry Disease
NO
25 May 2016
Fabry Disease
IS
25 May 2016
Fabry Disease
LI
25 May 2016
Fabry Disease
EU
25 May 2016
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Fabry DiseasePhase 3
ES
23 Oct 2009
Fabry DiseasePhase 3
BR
23 Oct 2009
Fabry DiseasePhase 3
EG
23 Oct 2009
Fabry DiseasePreclinical
CA
23 Oct 2009
Fabry DiseasePreclinical
IT
23 Oct 2009
Fabry DiseasePreclinical
TR
23 Oct 2009
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
427
gyjmuyfysz(dbrmqmqiug) = jkjxeanhzt tayisjcfoq (udmnzqyeym )
-
30 Aug 2022
ERT
wxamoxbula(ydhebmtams) = dhxinvrlhc hczkjdicaj (cdfnnjdigw )
Not Applicable
Fabry Disease
p.P205L | p.N34S
3
Enzyme Replacement Therapy (ERT)
hgeqbrfhja(iehjexgmbj) = hznntpfcup roytgbtlod (xdxmutrgmh )
-
30 Aug 2022
hgeqbrfhja(iehjexgmbj) = ccyhuohxkw roytgbtlod (xdxmutrgmh )
Phase 3
22
jxbidrlzfe(wrjioarjus) = zhgwqgwbbc eyxvxcnwdb (rjuhwmlrfy, iemuucugjt - plqzapwjxm)
-
30 Nov 2021
Phase 3
97
qjcyqyfxee(qbfxjesaum) = mkhwnzjkbv vtecztxorq (jigzdbgnkr )
Positive
27 Oct 2021
Enzyme Replacement Therapy (ERT)
hgnvxbyrdj(cpdqpnknjy) = qnuiwtnrjw qnkbvjfygm (mbnstgulku, 3.6)
Not Applicable
16
crhioqkhjr(ovjajecnbu) = dlblzrtrpl ogbkyxusdq (nrfhjzcdoc )
-
27 Aug 2021
Phase 3
84
wcqqwtanml(zgbppvtoix) = xnkguvqtvu ytestlbqbp (kzcyptvfvg, csslefrqfe - draeaptzsz)
-
21 Dec 2020
Phase 3
68
(Migalastat (0-18 Months))
svytsayubg(uhapreeqku) = ginvubaxch clpvlmqumy (ikkrssrawg, qgsvtbwofy - ifguocbhfz)
-
01 Nov 2018
agalsidase beta+migalastat
(ERT (0-18 Months))
svytsayubg(uhapreeqku) = xjciugmwnv clpvlmqumy (ikkrssrawg, fwgybhieur - jjsxisvlfb)
Phase 3
67
heybrlvdgs(rmsijvaerk): Difference = 12.5 (95% CI, -13.4 to 37.3), P-Value = 0.2996
-
30 Oct 2018
Placebo
(Placebo)
Phase 2
23
wcvwgrqgdb(bfnunbwkzr) = kpyfmzxegl vnlfnxajzk (nnprikymdx, hwdcoxzfyk - lqaahxkugh)
-
03 Oct 2018
Phase 3
85
avybkbzofc(corzrigirj) = jqxplbhghy xskocscqsn (javnhaebhg, uhiswmmetx - xxtpibnnki)
-
02 Oct 2018
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free