Drugs / Bavdegalutamide
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05177042 | May 2022 → Jul 2024 | metastatic prostate carcinoma | Arvinas Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03888612 | Mar 2019 → Apr 2024 | metastatic prostate carcinoma | Arvinas Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2023-10-22 | Arvinas Inc. | Results Potential of Arvinas’ PROTAC® AR Degraders Reinforced by 11.1 months rPFS with Bavdegalutamide and Updated Positive Interim Data from Second Generation ARV-766 in mCRPC arvinas.com ↗
Data presented at the European Society for Medical Oncology from the Phase 1/2 trial with bavdegalutamide showed 11.1 months radiographic progression free survival in mCRPC patients with tumors harboring AR 878/875 mutations |
| 2022-02-17 | Arvinas Inc. | Results Arvinas PROTAC® Protein Degrader Bavdegalutamide (ARV-110) Continues to Demonstrate Clinical Benefit in Men with Metastatic Castration-Resistant Prostate Cancer arvinas.com ↗
Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced completed Phase 1 and interim Phase 2 ARDENT data for bavdegalutamide (ARV-110), a novel PROTAC® degrader targeting the androgen receptor (AR). |
| 2022-02-14 | Arvinas Inc. | Results Arvinas Announces New Data from Completed Phase 1 Dose Escalation and Ongoing Phase 2 ARDENT Expansion Cohort with Novel PROTAC® Degrader Bavdegalutamide (ARV-110) to be Presented at 2022 ASCO GU Meeting arvinas.com ↗
These data show that bavdegalutamide reduced prostate-specific antigen (PSA) levels greater than or equal to 50% (PSA 50 ) in 46% of patients with tumors harboring AR T878X/H875Y (T878X = T878A or T878S) mutations. |
| 2020-12-14 | Arvinas Inc. | Results Arvinas Releases Interim Clinical Data Further Demonstrating the Powerful Potential of PROTAC® Protein Degraders ARV-471 and ARV-110 arvinas.com ↗
Increases in exposure are associated with increased frequency of PSA reductions. |
| 2020-05-29 | Arvinas Inc. | Results Arvinas Releases Updated Dose Escalation Data from Clinical Trial of PROTAC® Protein Degrader ARV-110 in Patients with Metastatic Castration-Resistant Prostate Cancer arvinas.com ↗
Both responses, which were in patients at the 140 mg dose, were achieved by ARV-110 despite prior enzalutamide, abiraterone, chemotherapy, and other therapies. |
| 2020-05-13 | Arvinas Inc. | Results Arvinas Announces Updated Phase 1 Data Demonstrating Clinical Activity of PROTAC® Protein Degrader ARV-110 in Patients with Refractory Prostate Cancer arvinas.com ↗
The abstract describes two patients with ongoing confirmed prostate-specific antigen (PSA) responses, including one with an unconfirmed partial tumor response. |
| 2019-10-23 | Arvinas Inc. | Results Arvinas Presents a Platform Update, Including Initial Data from the First Two Clinical Trials of PROTAC® Targeted Protein Degraders arvinas.com ↗ |
| 2019-05-29 | Arvinas Inc. | Regulatory Arvinas Receives Fast Track Designation for its Targeted Protein Degrader ARV-110 as a Treatment for Men with Metastatic Castration-Resistant Prostate Cancer arvinas.com ↗
Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies that degrades disease-causing proteins, today announced that its lead PROTAC® protein degrader, ARV-110, has been granted Fast Track designation by the U.S. Food and Drug Administration ( FDA ) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed after treatment with two or more systemic therapies. |
| 2019-01-04 | Arvinas Inc. | Regulatory Arvinas Receives Authorization to Proceed for its IND Application for PROTAC™ Therapy to Treat Patients with Metastatic Castration-Resistant Prostate Cancer arvinas.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has cleared the company’s investigational new drug application (IND) for ARV-110 |
| 2018-02-09 | Arvinas Inc. | Results Arvinas Presents New Preclinical Data on Oral Androgen Receptor PROTAC® ARV-110 at ASCO 2018 Genitourinary Cancers Symposium arvinas.com ↗
The studies show that degradation of the androgen receptor with ARV-110 leads to inhibition of AR target gene expression and the proliferation of prostate cancer cell lines. |
All press releases naming this drug 13 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bavdegalutamide | “Bavdegalutamide (ARV-110) is a PROteolysis TArgeting Chimera (PROTAC) protein degrader that recruits the cereblon-containing E3 ubiquitin ligase to direct the...” PMID 39670468 ↗ Apr 2025 |
| Known as | ARV-110 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03888612 ↗ |
| Known as | ARV-110 (PROTAC) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4862963 ↗ |
| Modality | Small molecule | — CHEMBL4862963 ↗ |
| Route | Oral | “Part A: Oral tablet(s), once or twice daily in 28 day cycles” NCT03888612 ↗ |
| Target | AR | “Bavdegalutamide (ARV-110) is a PROteolysis TArgeting Chimera (PROTAC) protein degrader that recruits the cereblon-containing E3 ubiquitin ligase to direct the...” PMID 39670468 ↗ Apr 2025 |