adagrasib
Trade name: Krazati
Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Dec 12, 2022
Clinical trial activity
30 trials · 19 clinical orgs · 2 marketing orgs
Phase 1
18
Phase 2
18
Phase 3
4
Phase 4
0
Earliest trial started Jan 15, 2019 (NCT03785249)
Timeline
2010s
- Jan 1, 2019
Mirati Therapeutics Inc. — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Mirati Therapeutics Inc. — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2021
Mirati Therapeutics Inc. — Earliest Phase 3 Sponsor(trial)
- Jun 7, 2021
Orphan Drug Designation
- Dec 12, 2022
Mirati Therapeutics Inc. — Earliest FDA Approval
- Dec 12, 2022
Bristol-Myers — Marketing Organization
- Dec 12, 2022
Mirati Therapeutics Inc. — Marketing Organization
- Dec 12, 2022
Mirati Therapeutics Inc. — NDA Secondary Org
- Dec 12, 2022
Mirati Therapeutics Inc. — NDA Organization
Indications
Approved for
Studied for
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Colonic Neoplasms · Phase 1
- Colorectal Neoplasms · Phase 3
- Healthy Volunteers · Phase 1
- Intestinal Neoplasms · Phase 1
- Lung Neoplasms · Phase 3
- Mutation · Phase 1/Phase 2
- Neoplasm Metastasis · Phase 1/Phase 2
- Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 1
- Proto-Oncogene Proteins p21(ras) · Phase 2
- ras GTPase-Activating Proteins · Phase 1/Phase 2
- ras Proteins · Phase 2
- Small Cell Lung Carcinoma · Phase 3
Mechanism of action
- GTPase KRasANTAGONIST
KRAS antagonist
- GTPase KRasINHIBITOR
GTPase KRas inhibitor
Approval history
- approvedAcceleratedFast trackBreakthroughDec 12, 2022
Chemistry & pharmacology
Loading structure…
SMILES
C=C(F)C(=O)N1CCN(c2nc(OC[C@@H]3CCCN3C)nc3c2CCN(c2cccc4cccc(Cl)c24)C3)C[C@@H]1CC#N- Mol. weight
- 604.13 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4594350 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07288034 | Phase 2 | Sep 21, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT06875310 | Phase 3 | Apr 30, 2025 | Mirati Therapeutics Inc. |
| NCT06764771 | Phase 1 | Mar 25, 2025 | Bristol-Myers Squibb |
| NCT06801418 | Phase 1 | Feb 4, 2025 | Bristol-Myers Squibb, Mirati Therapeutics Inc. |
| NCT05848843 | Phase 1 | Oct 30, 2024 | AstraZeneca, Mirati Therapeutics Inc., University of Texas at Houston |
| NCT06497556 | Phase 3 | Sep 23, 2024 | Chugai, Roche |
| NCT06412198 | Phase 1/Phase 2 (Phase 2) | Aug 28, 2024 | University of Texas at Houston |
| NCT06248606 | Phase 2 | Aug 6, 2024 | Hoosier Cancer Research Network, Mirati Therapeutics Inc., University of Virginia |
| NCT06130254 | Phase 1 | May 31, 2024 | Mirati Therapeutics Inc., University of Texas at Houston |
| NCT06039384 | Phase 1 | Jan 10, 2024 | Incyte, Mirati Therapeutics Inc. |
| NCT05722327 | Phase 1 | Dec 6, 2023 | Mirati Therapeutics Inc., University of Texas at Houston |
| NCT06024174 | Phase 1/Phase 2 (Phase 2) | Nov 9, 2023 | Bristol-Myers Squibb |
| NCT05840510 | Phase 1/Phase 2 (Phase 2) | Aug 7, 2023 | Aadi, LLC, Mirati Therapeutics Inc. |
| NCT05924152 | Phase 1 | Jun 29, 2023 | Mirati Therapeutics Inc. |
| NCT05673187 | Phase 2 | Jun 12, 2023 | ETOP IBCSG Partners Foundation, Mirati Therapeutics Inc., William Beaumont Hospitals |
| NCT05853575 | Phase 2 | Apr 5, 2023 | Mirati Therapeutics Inc. |
| NCT05634525 | Phase 1 | Mar 31, 2023 | Mirati Therapeutics Inc., University of Texas at Houston |
| NCT05472623 | Phase 2 | Nov 20, 2022 | Bristol-Myers Squibb, Johns Hopkins University, Mirati Therapeutics Inc. |
| NCT05578092 | Phase 1/Phase 2 (Phase 2) | Nov 4, 2022 | Mirati Therapeutics Inc. |
| NCT05375994 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2022 | Mirati Therapeutics Inc., Verastem, Inc. |
Showing 20 of 30 trials
Page 1 / 2
Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Mirati Therapeutics Inc. | For profit | 25 | 15 | 4 | 2019 |
| Bristol-Myers Squibb | For profit | 5 | 2 | 2 | 2020 |
| University of Texas at Houston | Academic/Hospital | 5 | 5 | 2 | 2023 |
| Aadi, LLC | For profit | 1 | 0 | 1 | 2023 |
| AstraZeneca | For profit | 1 | 0 | 1 | 2024 |
| Boehringer Ingelheim | For profit | 1 | 0 | 1 | 2021 |
| Chugai | For profit | 1 | 0 | 1 | 2024 |
| City of Hope National Medical Center | Academic/Hospital | 1 | 1 | 1 | 2026 |
| ETOP IBCSG Partners Foundation | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Hoosier Cancer Research Network | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Incyte | For profit | 1 | 1 | 1 | 2024 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2026 |
| Novartis | For profit | 1 | 0 | 1 | 2020 |
| Roche | For profit | 1 | 1 | 1 | 2024 |
| University of Virginia | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Verastem, Inc. | For profit | 1 | 1 | 1 | 2022 |
| William Beaumont Hospitals | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Zai Lab Pty. Ltd. | For profit | 1 | 1 | 1 | 2022 |
19 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bristol-Myers | For profit | MKTG | Dec 12, 2022 |
| Mirati Therapeutics Inc. | For profit | MKTG | Dec 12, 2022 |
| Mirati Therapeutics Inc. | For profit | NDA2 | Dec 12, 2022 |
| Mirati Therapeutics Inc. | For profit | NDA | Dec 12, 2022 |