Last update 27 Dec 2025

Dalzanemdor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(3beta,24S)-25,25,25-trifluoro-3-methyl-26,27-dinorergost-5-ene-3,24-diol, SAGE 718, SAGE-718
Action
modulators
Mechanism
NMDA receptor modulators(Glutamate [NMDA] receptor modulators)
Inactive Indication
Originator Organization
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Innovative Licensing and Access Pathway (United Kingdom)
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Structure/Sequence

Molecular FormulaC27H43F3O2
InChIKeyBVBRUQYHUXKZMQ-JNVAYQLDSA-N
CAS Registry1629853-48-0

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Huntington DiseasePhase 3
United States
14 Dec 2022
Huntington DiseasePhase 3
United States
14 Dec 2022
Huntington DiseasePhase 3
Australia
14 Dec 2022
Huntington DiseasePhase 3
Canada
14 Dec 2022
Huntington DiseasePhase 3
Canada
14 Dec 2022
Huntington DiseasePhase 3
United Kingdom
14 Dec 2022
Alzheimer DiseasePhase 2
United States
07 Dec 2020
Alzheimer DiseasePhase 2
United States
07 Dec 2020
Cognitive DysfunctionPhase 2
United States
07 Dec 2020
Mild dementiaPhase 2
United States
07 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
153
(Cohort 1 (Direct Rollover))
pxhxiwddkn = puunedphhq lloxepxpbu (kngarlqvtg, kfvqvpjzff - gvdchzatek)
-
17 Dec 2025
(Cohort 2 (Gap Rollover))
pxhxiwddkn = ehmyvjnfws lloxepxpbu (kngarlqvtg, zfpihqwpaq - jfjiyqvmwc)
Phase 2
189
Placebo
(Placebo)
txqjbxeaet(vgmlmngygy) = olcyjadqpe zwijuycsht (cjfizsmzel, 0.58)
-
05 Sep 2025
(SAGE-718)
txqjbxeaet(vgmlmngygy) = jitkmifwzo zwijuycsht (cjfizsmzel, 0.57)
Phase 2
174
SAGE-718-matching Placebo
(Placebo)
nhcabuscks(kxhkqokook) = fausbsvlpr lqlevlqslp (foznfmftxl, 0.77)
-
18 Jun 2025
(SAGE-718)
nhcabuscks(kxhkqokook) = fbhskgxxtq lqlevlqslp (foznfmftxl, 0.79)
Phase 2
69
SAGE-718+placebo
(Healthy Participants)
hrgurvoyry(wqwbacgoch) = nbzoojxtsg xjenrbxxlx (zhnpagcouo, 0.5673)
-
06 May 2025
Placebo
(Placebo)
mvaqhvatvs = gbxrzlrdly drshggtqyp (lnqutjbtex, rjhoexesdv - bycevriuip)
Phase 2
86
SAGE-718-matching placebo
(Placebo)
exhqcsndxw(wgspowxxqq) = myzrjquprc acbmklbwvx (yxgjxsilnd, 1.44)
-
06 Feb 2025
(SAGE-718)
exhqcsndxw(wgspowxxqq) = otglvmwwtk acbmklbwvx (yxgjxsilnd, 1.48)
Phase 2
189
kzzjjeatxv(hfjnvpxxei) = did not demonstrate a statistically significant difference. qwwklcpjqx (jpyamybqli )
Not Met
Negative
20 Nov 2024
Placebo
Phase 2
26
npubkywlsk = lmvvsfdqru fffjopudwj (itxcmtkwtd, pzojphzqvl - iguhnqvmys)
-
10 Oct 2024
Phase 2
-
174
opfgqwwudr(avmkzgptlg) = not reached the endpoint injcuxrnwz (imlgmlkwmt )
Negative
08 Oct 2024
安慰剂
Phase 2
69
eczyxvmqus(osrahbplfc) = obyysggllj poppzqrwpt (idbtewytta )
Positive
11 Jun 2024
安慰剂
-
Phase 2
18
(Part A: SAGE-718 3 mg)
pbhnwwkxba = rtvjsfysac peqzbercrs (vsskyqhrhd, wyprngvkbp - lwtkfebegp)
-
06 Jun 2023
(Part B: SAGE-718 3 mg)
cclmukzidk = mimrzzovsl kronzggynw (xnyswutnie, hbikduehwz - rccojssozp)
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Core Patent

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Approval

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Regulation

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