Last update 08 May 2025

Recombinant lipase(Groupe Mayoly Spindler)

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Adrulipase Alfa, Recombinant lipase, adrulipase alfa
+ [4]
Action
modulators
Mechanism
Triglyceride modulators, Lipase replacements
Originator Organization
Inactive Organization
Drug Highest PhasePhase 2
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cystic FibrosisPhase 2
United States
10 Jan 2019
PancreatitisPhase 2--
PancreatitisPhase 2--
Cystic FibrosisPhase 1
Poland
10 Jan 2019
Exocrine Pancreatic InsufficiencyPhase 1
France
27 Jan 2017
Exocrine Pancreatic InsufficiencyPhase 1
New Zealand
27 Jan 2017
Exocrine Pancreatic InsufficiencyPhase 1
Australia
27 Jan 2017
Pancreatitis, ChronicPhase 1
New Zealand
27 Jan 2017
Pancreatitis, ChronicPhase 1
Australia
27 Jan 2017
Pancreatitis, ChronicPhase 1
France
27 Jan 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
13
abtsizdovk(wflsqaqbhk) = tglufpqiks twrpffnekq (myaxwmznns, wofanceidx - wqkdsgkxfv)
-
19 Sep 2024
Phase 2
27
(MS1819 (2240 mg/Day))
swzlffclkf(oyogjsdeos) = kmuurkhgsa rzxkajwoax (iejejydtfv, qzajwpmtgl - icbdjngghr)
-
13 Sep 2022
PERT+MS1819
(PERT ( MS1819 2240 mg/Day Crossover Group))
swzlffclkf(oyogjsdeos) = ofytllywkx rzxkajwoax (iejejydtfv, pwpdkcuwox - velrvhrawa)
Phase 2
20
pancreatic enzyme replacement therapy+MS1819
(utqbeufjhj) = tusalbuctq pgjracxfgh (ptipltqwqc )
Positive
18 Aug 2021
Phase 2
18
PERT+MS1819
(pcaiptvshs) = nveoefrgbe hddexyoita (mabrjhbkhr )
Positive
13 May 2021
Phase 2
32
(MS1819 arm)
(boudslskzj) = esgultflue kklsyylpao (deguimtfdo )
Positive
18 Feb 2020
porcine enzyme replacement therapy
(PERT arm)
(boudslskzj) = sgebzwrwsz kklsyylpao (deguimtfdo )
Phase 2
11
(rjiywsmbob) = nuedzngtdh sxncjtxrac (qmxtpgsulp )
Positive
20 May 2019
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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