Modality
Gene Therapy
MOA
MDM2i
Target
AHR
Pathway
Apoptosis
BCC
Development Pipeline
Preclinical
~Jan 2013
→ ~Apr 2014
Phase 1
~Jul 2014
→ ~Oct 2015
Phase 2
~Jan 2016
→ ~Apr 2017
Phase 3
~Jul 2017
→ ~Oct 2018
NDA/BLA
~Jan 2019
→ ~Apr 2020
Approved
Jul 2020
→ Sep 2029
ApprovedCurrent
NCT07728254
56 pts·BCC
2022-09→2029-09·Active
NCT05942865
824 pts·BCC
2024-08→2026-07·Terminated
NCT06663093
2,228 pts·BCC
2020-07→2026-08·Recruiting
3,108 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-07-103mo awayPh3 Readout· BCC
2026-08-014mo awayPh3 Readout· BCC
2029-09-273.5y awayPh3 Readout· BCC
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Recruit…
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2026-07-10 · 3mo away
BCC
Ph3 Readout
2026-08-01 · 4mo away
BCC
Ph3 Readout
2029-09-27 · 3.5y away
BCC
RecruitingActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07728254 | Approved | BCC | Active | 56 | 6MWD |
| NCT05942865 | Approved | BCC | Terminated | 824 | PASI75 |
| NCT06663093 | Approved | BCC | Recruiting | 2228 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2901 | Pfizer | Phase 2 | AHR | |
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| Rimasertib | Exelixis | Phase 3 | B7-H3 | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR |