zongertinib
Trade name: Hernexeos
Small moleculeapproved
Approved
Aug 8, 2025
Clinical trial activity
14 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
11
Phase 2
4
Phase 3
2
Phase 4
0
Earliest trial started Jun 22, 2021 (NCT04886804)
Timeline
2020s
- Jan 1, 2021
Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2024
Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2024
Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)
- Aug 8, 2025
Earliest FDA Approval
- Aug 8, 2025
Boehringer Ingelheim — Marketing Organization
Indications
Approved for
Mechanism of action
ERBB2 inhibitor
Approval history
- approvedPriority reviewAug 8, 2025
Chemistry & pharmacology
Loading structure…
SMILES
C=CC(=O)NC1CCN(c2ncc3ncnc(Nc4ccc(Oc5ccc6c(c5)ncn6C)c(C)c4)c3n2)CC1- Mol. weight
- 535.61 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL5314498 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07195695 | Phase 3 | Dec 5, 2025 | Boehringer Ingelheim |
| NCT06692322 | Phase 1 | Dec 5, 2024 | Boehringer Ingelheim |
| NCT06581432 | Phase 2 | Sep 12, 2024 | Boehringer Ingelheim |
| NCT06504862 | Phase 1 | Aug 19, 2024 | Boehringer Ingelheim |
| NCT06494761 | Phase 1 | Jul 22, 2024 | Boehringer Ingelheim |
| NCT06324357 | Phase 1/Phase 2 (Phase 2) | May 23, 2024 | Boehringer Ingelheim |
| NCT06360081 | Phase 1 | Apr 26, 2024 | Boehringer Ingelheim |
| NCT06151574 | Phase 3 | Jan 15, 2024 | Boehringer Ingelheim |
| NCT06075277 | Phase 1 | Oct 19, 2023 | Boehringer Ingelheim |
| NCT06028464 | Phase 1 | Sep 11, 2023 | Boehringer Ingelheim |
| NCT05879991 | Phase 1 | Aug 10, 2023 | Boehringer Ingelheim |
| NCT05833139 | Phase 1 | Apr 14, 2023 | Boehringer Ingelheim |
| NCT05380947 | Phase 1 | Jun 23, 2022 | Boehringer Ingelheim |
| NCT04886804 | Phase 1 | Jun 22, 2021 | Boehringer Ingelheim |
Showing 14 of 14 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Boehringer Ingelheim | For profit | 14 | 14 | 3 | 2021 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Boehringer Ingelheim | For profit | MKTG | Aug 8, 2025 |