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Evidence dashboardStudies since 2005Updated Jul 31, 2026

LarazotideClinical Trials.

A source-linked view of every Larazotide study in the current snapshot—status, phase, enrollment, results, publications, locations and changes over time.

Total trials
31
Recruiting
2
Completed
22
Terminated
4
Results posted
12
Average enrollment
60
Countries
19
Highest phase
Phase 3

Largest indexed study

450 participants · NCT06906367 →

Developer / research origin

9 Meters Biopharma

Evidence summary

Activity is not efficacy.

Larazotide appears in 31 indexed studies: 2 recruiting, 22 completed and 12 with registry results posted. The highest registered development stage in this snapshot is Phase 3. These counts measure registry activity; they do not establish that Larazotide is safe or effective.

Review the design, endpoints, population, protocol changes, statistical analysis and publications before drawing conclusions.

Development history

Trial timeline.

Evidence timeline

2005—2026

20052006200620062006200720092011201120112015201820192019202220262026

Velocity

Larazotide studies by start year

Study start year · indexed snapshot

9752020052005: 1 trials2006: 6 trials2007: 2 trials2008: 1 trials20092009: 2 trials2010: 0 trials2011: 9 trials2012: 0 trials20132013: 0 trials2014: 1 trials2015: 1 trials2016: 0 trials20172017: 0 trials2018: 1 trials2019: 2 trials2020: 0 trials20212021: 1 trials2022: 1 trials2023: 1 trials2024: 0 trials20252025: 0 trials20262026: 2 trials

Development

Trials by phase

Early Phase 10
Phase 17
Phase 213
Phase 39
Phase 40

Current studies

Recruiting or active

Completed studies

Finished records

Stopped studies

Withdrawn or terminated

Showing 6 of 22 studies

Full study index

Search Larazotide trials.

Add status, phase, condition, country, result and publication filters inside this molecule’s indexed study set.

31 matching studies

Latest publications

Follow the paper trail.

PMID 31889231 ↗Narita I, Ohashi T, Sakai N, Hamazaki T, Skuban N, Castelli JP, Lagast H, Barth JA. Efficacy and safety of migalastat in a Japanese population: a subgroup analysis of the ATTRACT study. Clin Exp Nephrol. 2020 Feb;24(2):157-166. doi: 10.1007/s10157-019-01810-w. Epub 2019 Dec 30.Linked from NCT02194985PMID 26252393 ↗Warnock DG, Bichet DG, Holida M, Goker-Alpan O, Nicholls K, Thomas M, Eyskens F, Shankar S, Adera M, Sitaraman S, Khanna R, Flanagan JJ, Wustman BA, Barth J, Barlow C, Valenzano KJ, Lockhart DJ, Boudes P, Johnson FK. Oral Migalastat HCl Leads to Greater Systemic Exposure and Tissue Levels of Active alpha-Galactosidase A in Fabry Patients when Co-Administered with Infused Agalsidase. PLoS One. 2015 Aug 7;10(8):e0134341. doi: 10.1371/journal.pone.0134341. eCollection 2015.Linked from NCT01196871PMID 33012654 ↗Feldt-Rasmussen U, Hughes D, Sunder-Plassmann G, Shankar S, Nedd K, Olivotto I, Ortiz D, Ohashi T, Hamazaki T, Skuban N, Yu J, Barth JA, Nicholls K. Long-term efficacy and safety of migalastat treatment in Fabry disease: 30-month results from the open-label extension of the randomized, phase 3 ATTRACT study. Mol Genet Metab. 2020 Sep-Oct;131(1-2):219-228. doi: 10.1016/j.ymgme.2020.07.007. Epub 2020 Aug 15.Linked from NCT01218659PMID 32994552 ↗Bichet DG, Aerts JM, Auray-Blais C, Maruyama H, Mehta AB, Skuban N, Krusinska E, Schiffmann R. Assessment of plasma lyso-Gb3 for clinical monitoring of treatment response in migalastat-treated patients with Fabry disease. Genet Med. 2021 Jan;23(1):192-201. doi: 10.1038/s41436-020-00968-z. Epub 2020 Sep 30.Linked from NCT01218659PMID 31934472 ↗Haninger-Vacariu N, El-Hadi S, Pauler U, Foretnik M, Kain R, Prohaszka Z, Schmidt A, Skuban N, Barth JA, Sunder-Plassmann G. Pregnancy Outcome after Exposure to Migalastat for Fabry Disease: A Clinical Report. Case Rep Obstet Gynecol. 2019 Dec 21;2019:1030259. doi: 10.1155/2019/1030259. eCollection 2019.Linked from NCT01218659PMID 27834756 ↗Hughes DA, Nicholls K, Shankar SP, Sunder-Plassmann G, Koeller D, Nedd K, Vockley G, Hamazaki T, Lachmann R, Ohashi T, Olivotto I, Sakai N, Deegan P, Dimmock D, Eyskens F, Germain DP, Goker-Alpan O, Hachulla E, Jovanovic A, Lourenco CM, Narita I, Thomas M, Wilcox WR, Bichet DG, Schiffmann R, Ludington E, Viereck C, Kirk J, Yu J, Johnson F, Boudes P, Benjamin ER, Lockhart DJ, Barlow C, Skuban N, Castelli JP, Barth J, Feldt-Rasmussen U. Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomised phase III ATTRACT study. J Med Genet. 2017 Apr;54(4):288-296. doi: 10.1136/jmedgenet-2016-104178. Epub 2016 Nov 10.Linked from NCT01218659PMID 27657681 ↗Benjamin ER, Della Valle MC, Wu X, Katz E, Pruthi F, Bond S, Bronfin B, Williams H, Yu J, Bichet DG, Germain DP, Giugliani R, Hughes D, Schiffmann R, Wilcox WR, Desnick RJ, Kirk J, Barth J, Barlow C, Valenzano KJ, Castelli J, Lockhart DJ. The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat. Genet Med. 2017 Apr;19(4):430-438. doi: 10.1038/gim.2016.122. Epub 2016 Sep 22.Linked from NCT01218659PMID 23176611 ↗Germain DP, Giugliani R, Hughes DA, Mehta A, Nicholls K, Barisoni L, Jennette CJ, Bragat A, Castelli J, Sitaraman S, Lockhart DJ, Boudes PF. Safety and pharmacodynamic effects of a pharmacological chaperone on alpha-galactosidase A activity and globotriaosylceramide clearance in Fabry disease: report from two phase 2 clinical studies. Orphanet J Rare Dis. 2012 Nov 24;7:91. doi: 10.1186/1750-1172-7-91.Linked from NCT00283959

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Commercial research listings, where present, are kept separate from clinical evidence and are not treatment recommendations.

DatabaseLarazotide database page →Research guideRead the Larazotide guide →Lab reportsSearch the COA ledger →Source registrySearch ClinicalTrials.gov ↗