CTT1057
NOVARTIS AG NVS NVSEF · Prostate Cancer; Prostatic Neoplasms; Recurrence
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- NOVARTIS AG NVS NVSEF Source: Company record for NOVARTIS AG (opens in a new tab)
- Indications
- Prostate Cancer; Prostatic Neoplasms; Recurrence Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 7 Sep 20211 linked trial
- Phase 3 Current stageFirst trial start 7 Sep 20212 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for CTT1057. Editors add each one with its source.
Filed application
No filed application is on record for CTT1057. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for CTT1057.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04838613ClinicalTrials.gov record for NCT04838613 (opens in a new tab)GuidePath | Study of Diagnostic Performance of [18F]CTT1057 in BCR | Phase 3 | Completed | 190 (actual) | 23 Nov 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04838613 (opens in a new tab) |
Posted results on ClinicalTrials.gov for GuidePath Serious adverse events (Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing.): Vidoflufolastat (18F) 1 of 171; Gallium (68Ga) Gozetotide 0 of 178 Source: ClinicalTrials.gov results for NCT04838613 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing GuidePath (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04838626ClinicalTrials.gov record for NCT04838626 (opens in a new tab)GuideView | Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection | Phase 2/3 | Completed | 195 (actual) | 24 Nov 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04838626 (opens in a new tab) |
Posted results on ClinicalTrials.gov for GuideView Serious adverse events (Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.): PET/CT Imaging With Vidoflufolastat (18F) 2 of 184 Source: ClinicalTrials.gov results for NCT04838626 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing GuideView (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as CTT1057.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT04838626 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04838613 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.