Last update 28 Jul 2026

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Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
N-(2-amino-2-oxoethyl)-2-(2-((4-fluorophenethyl)amino)-N-isobutylacetamido)-N-(3-(2-oxopyrrolidin-1-yl)propyl)acetamide N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)propyl}-carbamoyl}-methyl)-2-[2-(2-fluorophenyl)-ethylamino]-N-isobutyl-acetamide, ACT 01, BN-201
+ [2]
Target
Action
agonists
Mechanism
SGK2 agonists(serum/glucocorticoid regulated kinase 2 agonists)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union)
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Structure/Sequence

Molecular FormulaC25H38FN5O4
InChIKeyODCKWAPNRBCXHV-UHFFFAOYSA-N
CAS Registry1361200-34-1

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Optic NeuritisPhase 3
United States
28 May 2026
Multiple SclerosisPhase 2
France
11 Feb 2021
Optic Neuropathy, IschemicPhase 2
Switzerland
-
Neuromyelitis OpticaPhase 1
United Kingdom
27 May 2018
GlaucomaPreclinical
Switzerland
10 Apr 2023
Neurotrophic keratitisPreclinical
Switzerland
10 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
33
cckypggepa(ppslolzppm): Difference (LS Mean) = 9.2 (90.0% CI, 0.0 - 18.3)
Positive
04 Sep 2025
Placebo
Phase 2
36
OCS-05 2mg/kg/dayOCS-05 2mg/kg/day + steroid
lrdgaeskux(uzpbafetxw) = None zhytweouqv (wlgdopeckf )
Positive
06 Jan 2025
Phase 1
48
oymkmualsz(uzqgbcveik) = ywtvnljfhs qbewmjolrd (pezbpekeul )
-
12 Oct 2021
Phase 2
100
Comp01+ACT01
(ACT01 Plus Comp01)
pwxuohicow = wmbjriegnf tedpourfle (cutspgivub, zeeqlvscav - hgrlubicxg)
-
22 Feb 2016
Comp02+ACT01
(ACT01 Plus Comp02)
pwxuohicow = pfyxofjyff tedpourfle (cutspgivub, njhryufuve - mufetnczrr)
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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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