Modality
Radioligand
MOA
MDM2i
Target
WRN
Pathway
Neuroinflam
PTSD
Development Pipeline
Preclinical
~Feb 2010
→ ~May 2011
Phase 1
~Aug 2011
→ ~Nov 2012
Phase 2
~Feb 2013
→ ~May 2014
Phase 3
~Aug 2014
→ ~Nov 2015
NDA/BLA
~Feb 2016
→ ~May 2017
Approved
Aug 2017
→ May 2029
ApprovedCurrent
NCT06474849
27 pts·PTSD
2025-02→2029-05·Completed
NCT03057440
805 pts·PTSD
2017-08→2026-08·Terminated
832 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2026-08-165mo awayPh3 Readout· PTSD
2029-05-093.1y awayPh3 Readout· PTSD
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
Approved
Termina…
Approved
Complet…
Catalysts
Ph3 Readout
2026-08-16 · 5mo away
PTSD
Ph3 Readout
2029-05-09 · 3.1y away
PTSD
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06474849 | Approved | PTSD | Completed | 27 | OS |
| NCT03057440 | Approved | PTSD | Terminated | 805 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Capiglumide | BioNTech | Preclinical | CGRP |