Drugs / VIPIVOTIDE TETRAXETAN
VIPIVOTIDE TETRAXETAN
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07476001 | Mar 2026 → Sep 2027 expected | prostate carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-05-17 | Novartis Pharmaceuticals | Results New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic hormone-sensitive prostate cancer novartis.com ↗
Risk of PSA progression was 58% lower (HR 0.42; 95% CI: 0.30-0.59) in patients treated with Pluvicto plus SoC compared to SoC alone. |
| 2025-10-19 | Novartis Pharmaceuticals | Results PSMAddition data show Novartis Pluvicto™ delays progression to end-stage prostate cancer novartis.com ↗
Pluvicto delayed time to progression to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.70; 95% CI: 0.58, 0.84) 1 . |
| 2025-06-02 | Novartis Pharmaceuticals | Results Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer novartis.com ↗
At interim analysis, PSMAddition trial met its primary endpoint showing statistically significant and clinically meaningful benefit for Pluvicto™ plus hormone therapy versus hormone therapy alone, with positive trend in overall survival (OS) 1 |
| 2025-05-12 | BAMF Health | Regulatory Prostate Cancer Patients Now Have an Option Other Than Chemotherapy bamfhealth.com ↗
With this new indication, patients can now be considered for PSMA-targeted radiopharmaceutical therapy after treatment with ADT and ARPI. |
| 2024-02-28 | Radiopharm Theranostics, Ltd | Results Pilot Study Validates RAD Terbium-161 Radiotherapeutics radiopharmtheranostics.com ↗
The study demonstrated that 161Tb-PSMA-617 delivers markedly higher tumor-absorbed doses compared to 177Lu-PSMA-617, whereas the absorbed doses of the relevant organs at risk were only slightly higher. |
| 2023-10-23 | Novartis Pharmaceuticals | Results Novartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane setting novartis.com ↗
Phase III PSMAfore trial with Pluvicto™ met its primary endpoint of radiographic progression-free survival (rPFS) with a HR of 0.41 1 ; Pluvicto more than doubled median rPFS to 12.0 months per updated analysis* |
| 2023-04-11 | Bayer | Results Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting bayer.com ↗
Radium-223 demonstrates increased antitumor activity in combination with 177Lu-PSMA-617 in the intratibial LNCaP xenograft model of bone metastatic prostate cancer |
| 2022-12-05 | Novartis Pharmaceuticals | Results Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer novartis.com ↗
Today, Novartis announced the pivotal Phase III PSMAfore study with Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. |
| 2022-10-14 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Pluvicto® for patients with progressive, PSMA-positive metastatic castration-resistant prostate cancer novartis.com ↗
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto ® (INN: lutetium ( 177 Lu) vipivotide tetraxetan) (formerly referred to as 177 Lu-PSMA-617), a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy. |
| 2022-08-30 | Novartis Pharmaceuticals | Results Novartis presents new data in breast and prostate cancer at ESMO novartis.com ↗
Association between prostate-specific antigen decline and clinical outcomes in patients with metastatic castration-resistant prostate cancer in the VISION trial |
| 2022-03-23 | Novartis Pharmaceuticals | Regulatory Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer novartis.com ↗ |
| 2021-11-12 | Eckert & Ziegler Radiopharma GmbH | Regulatory Eckert & Ziegler Announces Clinical Trial Notification for Joint Clinical Trial in Japan ezag.com ↗
the Clinical Trial Notification (CTN) of a joint clinical study with Novartis Pharma K.K. (Japan) was accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for 68 Ga-PSMA-11, an investigational radioligand imaging agent and 177 Lu-PSMA-617 |
| 2021-08-05 | Noxopharm Limited | Results Veyonda Survival Advantage in LuPSMA Therapy Confirmed noxopharm.com ↗
Important animal study shows that adding Veyonda to 177lutetium-PSMA-617 results in regression of prostate cancer |
| 2021-06-24 | Novartis Pharmaceuticals | Results Positive survival data for Novartis investigational radioligand therapy 177Lu-PSMA-617 published in The New England Journal of Medicine novartis.com ↗ |
| 2021-06-04 | Noxopharm Limited | Results Noxopharm Set to Benefit From Novartis ASCO Data noxopharm.com ↗
The Novartis VISION study reported a median Overall Survival (mOS) of 15.3 months for 177Lutetium-PSMA-617 + standard of care versus 11.3 months for standard of care alone |
| 2021-06-03 | Novartis Pharmaceuticals | Results Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study novartis.com ↗ |
| 2021-05-31 | Noxopharm Limited | Results New Independent Trial Data Supports Potential of Veyonda noxopharm.com ↗
WARMTH study is first reported large-scale multi-national study of Novartis experimental drug, 177lutetium-PSMA-617, in late-stage prostate cancer and showed a median overall survival (mOS) of 11.6 months |
| 2021-03-05 | Noxopharm Limited | Results Noxopharm Presents to H.C. Wainwright Global Conference noxopharm.com ↗
Median Overall Survival: 19.7 monthsa remarkable result for this late stage of the disease |
| 2021-02-15 | Noxopharm Limited | Results LuPIN Survival Outcome Confirmed by Conference Presentation noxopharm.com ↗
Drug combination NOX66 (Veyonda) and 177lutetium-PSMA-617 delivers high response rates in heavily pre-treated men with end-stage prostate cancer |
| 2021-02-09 | Noxopharm Limited | Results Major Survival Benefit in Prostate Cancer Patients Announced noxopharm.com ↗
LuPIN drug combination of Veyonda and 177Lu-PSMA-617 (Novartis) results in half of all patients surviving at least 19.7 months, a ground-breaking outcome for men with end-stage (Stage 4) disease and no remaining treatment options |
| 2020-08-11 | Noxopharm Limited | Results Peer-Reviewed Publication Strengthens Case For Veyonda noxopharm.com ↗ |
| 2020-06-01 | Noxopharm Limited | Results ASCO 2020 Highlights NOX66 Potential in Late-Stage Cancer noxopharm.com ↗
Combination treatment (Veyonda + 177Lu-PSMA-617) was safe and well tolerated. |
| 2020-03-31 | Noxopharm Limited | Results Noxopharm Virtual Roadshow Corporate Presentation noxopharm.com ↗
Median OS was 17.1 months –a remarkable result at this late stage of the disease |
| 2020-02-27 | Noxopharm Limited | Results Noxopharm Corporate Presentation February 2020 noxopharm.com ↗
Median PFS quadrupled through the addition of Veyonda® (8.4 months vs 2.0 months with 177Lu-PSMA-617 alone) |
| 2020-02-14 | Noxopharm Limited | Results Pronounced survival benefit in LuPIN interim trial data noxopharm.com ↗
Median Overall Survival was very long (17.1 months), a remarkable outcome for end-stage prostate cancer |
| 2020-01-29 | Noxopharm Limited | Results Noxopharm Non-Deal Roadshow Presentation noxopharm.com ↗
In summary, combination therapy of Veyonda® and 177Lu-PSMA-617 shows benefits to patients well above that achieved with 177Lu-PSMA-617 therapy alone and underscores the Company’s confidence in Veyonda® eventually becoming a standard drug in the management of prostate cancer |
| 2020-01-15 | Noxopharm Limited | Results Noxopharm Corporate Presentation noxopharm.com ↗
Interim results from the LuPIN study suggest that Veyonda® is also boosting the response to 177Lu-PSMA-617 (Novartis), enabling more men to complete their full course of radiation therapy, again, in a well tolerated way |
| 2019-11-12 | Noxopharm Limited | Results LuPIN Data Being Presented To Conference noxopharm.com ↗
Within the limits of comparing data sets from different studies, combination therapy was superior to monotherapy in terms of: • men able to undergo a 4th treatment cycle (69% vs 21%) • a PSA reduction of >50% (69% vs 36%) • overall progression-free survival based on PSA levels (7.8 vs 3.4 months). |
| 2019-09-30 | Noxopharm Limited | Results Further Review Shows Major Clinical Benefits from Veyonda noxopharm.com ↗ |
| 2019-09-17 | Noxopharm Limited | Results Veyonda and Radiotherapy Profiled at Key Oncology Meeting noxopharm.com ↗ |
| 2019-09-16 | Noxopharm Limited | Results NOX EGM Chairman's Address and Presentation noxopharm.com ↗
The investigators recently combined the two sets of data to provide a comparison and this was accepted for presentation at a conference in mid-November 2019. |
| 2019-06-26 | Noxopharm Limited | Results Conference Hears of Positive Interim Data from LuPIN Trial noxopharm.com ↗
Overall 69% PSA response rate (>50% reduction in PSA levels) with 177Lu-PSMA-617 + Veyonda |
| 2019-05-20 | Noxopharm Limited | Results LuPIN Trial Demonstrates High Rates of Response noxopharm.com ↗
75% of men treated with Veyonda 800 mg and 177Lu-PSMA-617 achieved a PSA response. |
| 2018-04-17 | Noxopharm Limited | Results St Vincent's Hospital study passes first milestone noxopharm.com ↗
Promising clinical response in 3 of 4 patients on lowest NOX66 dosage. |
All press releases naming this drug 36 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VIPIVOTIDE TETRAXETAN | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594280 ↗ |
| Known as | DKFZ-PSMA-617 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594280 ↗ |
| Known as | PSMA-617 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07476001 ↗ |
| Known as | Vipivotida tetraxetan | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594280 ↗ |
| Modality | Other / unclassified | “targeted radioligand therapy (TRT)” NCT07476001 ↗ |
| Route | Intravenous | “IV at 7.4GBq (200mCi)” NCT07476001 ↗ |