Modality
Peptide
MOA
SHP2i
Target
RET
Pathway
Ferroptosis
CholangiocarcinomaPSP
Development Pipeline
Preclinical
~Jan 2015
→ ~Apr 2016
Phase 1
~Jul 2016
→ ~Oct 2017
Phase 2
Jan 2018
→ Mar 2029
Phase 2Current
NCT05811085
1,539 pts·Cholangiocarcinoma
2018-01→2029-03·Not yet recruiting
NCT06074312
28 pts·PSP
2020-02→2027-07·Completed
1,567 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-07-051.3y awayPh3 Readout· PSP
2029-03-273.0y awayPh3 Readout· Cholangiocarcinoma
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
P2/3
Not yet…
P2/3
Complet…
Catalysts
Ph3 Readout
2027-07-05 · 1.3y away
PSP
Ph3 Readout
2029-03-27 · 3.0y away
Cholangiocarcinoma
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05811085 | Phase 2/3 | Cholangiocarcinoma | Not yet recr... | 1539 | VA |
| NCT06074312 | Phase 2/3 | PSP | Completed | 28 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| RHH-5389 | Roche | Preclinical | RET | |
| Fixanesiran | AbbVie | Preclinical | RET | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| Doxacagene | Sanofi | Approved | PSMA | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| ARG-3458 | Argenx | Preclinical | RET | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| Nirafotisoran | Jazz Pharma | Phase 2/3 | TROP-2 | |
| 369-4107 | Hansoh Pharma | Phase 2 | TNFα |