Drugs / 68Ga-Pentixafor
68Ga-Pentixafor
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 07 trials | ||||||
| Phase 0 | NCT07007325 | Sep 2026 → Sep 2028 expected | small cell lung carcinoma | Institut Cancerologie de l'Ouest | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06086327 | Jun 2023 → Dec 2024 | thymoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT05093335 | Oct 2021 → Oct 2027 expected | Erdheim-Chester disease, histiocytic and dendritic cell neoplasm, non-Hodgkin lymphoma, plasma cell myeloma +1 | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 0 | NCT05364177 | Aug 2021 → Aug 2024 | plasma cell myeloma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT04504526 | Aug 2020 → Dec 2024 | leukemia, plasma cell myeloma | First Affiliated Hospital of Fujian Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT03436342 | Jun 2019 → Mar 2020 | plasma cell myeloma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT03335670 | Nov 2017 → Dec 2029 expected | neuroendocrine neoplasm | Yusuf Menda | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07350707 | Jun 2023 → Mar 2026 overdue | Cushing syndrome | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06246357 | Sep 2024 → Dec 2027 expected | Cushing syndrome, hyperaldosteronism | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06478875 | Jun 2024 → Jun 2026 overdue | primary aldosteronism | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05321862 | Mar → May 2023 | plasma cell myeloma | Nantes University Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT04561492 | Sep 2021 → Dec 2029 expected | plasma cell myeloma | Nantes University Hospital | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06125028 | May 2024 → Jul 2025 | marginal zone lymphoma | Pentixapharm AG | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable2 trials | ||||||
| — | NCT06871176 | Apr 2025 → Mar 2028 expected | plasma cell myeloma | University Health Network, Toronto | Recruiting | No outcome recorded |
| — | NCT05255926 | Mar 2022 → Dec 2026 expected | hematopoietic and lymphoid cell neoplasm | Zhongnan Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-07-09 | Pentixapharm AG | Regulatory Pentixapharm erhält FDA-Fast-Track-Status für Phase-3-Diagnostikum [⁶⁸Ga]Ga-PentixaFor pentixapharm.com ↗
In ihrer Mitteilung stellte die FDA fest, dass der Antrag von Pentixapharm die Kriterien für den Fast-Track-Status erfüllt und [⁶⁸Ga]Ga-PentixaFor entsprechend als Fast-Track-Produkt für die diagnostische Subtypisierung erwachsener Patientinnen und Patienten mit bestätigtem primärem Aldosteronismus eingestuft wird. |
| 2026-07-09 | Pentixapharm AG | Regulatory Ad-hoc: Pentixapharm erhält FDA-Fast-Track-Status für [⁶⁸Ga]Ga-PentixaFor zur Subtypisierung des primären Aldosteronismus pentixapharm.com ↗
Der Pentixapharm Holding AG, Berlin (ISIN DE000A40AEG0, WKN A40AEG) („Gesellschaft“), ist von der US-amerikanischen Arzneimittelbehörde FDA (U.S. Food and Drug Administration) mitgeteilt worden, dass sie ihrem Entwicklungskandidaten [⁶⁸Ga]Ga-PentixaFor den Fast-Track-Status zuerkannt hat. |
| 2026-06-09 | Pentixapharm AG | Regulatory Pentixapharm gibt FDA-Freigabe der Phase-3-Studie PANDA bekannt: Grünes Licht für ein kardiovaskuläres First-in-Class Diagnostikprogramm pentixapharm.com ↗
“The Phase 3 IND clearance is a critical milestone confirming that [⁶⁸Ga]Ga-PentixaFor has reached the technological maturity required for pivotal clinical execution,” said Erik Merten, Chief Technology Officer of Pentixapharm. |
| 2026-06-09 | Pentixapharm AG | Regulatory Adhoc: FDA erteilt „Study May Proceed“ für PANDA Phase-3-Studie; beabsichtigte Bezugsrechtskapitalerhöhung im Volumen von bis zu 10 Mio. Aktien; BaFin-Bilanzkontrolle des Konzernabschlusses 2024 pentixapharm.com ↗
Die Pentixapharm Holding AG (ISIN: DE000A40AEG0) hat für ihr Lead-Programm PentixaFor von der FDA plangemäß innerhalb der 30-Tage-Frist die Freigabe für den Investigational New Drug (IND)-Antrag erhalten. |
| 2026-06-09 | Pentixapharm AG | Regulatory [68Ga]Ga-PentixaFor in Primärem Aldosteronsimus: Milliardenpotenzial in einem unterversorgten Massenmarkt pentixapharm.com ↗
Die Pentixapharm Holding AG hat heute die positive Rückmeldung der FDA („study may proceed“) zum Start der PH III PANDA Studie mit [68Ga]Ga-PentixaFor bekannt gegeben. |
| 2026-05-10 | Pentixapharm AG | Regulatory Pentixapharm Announces IND Submission to FDA for Phase 3 PANDA Study of First-in-Class CXCR4-Targeted Cardiovascular Diagnostic pentixapharm.com ↗
Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech developing novel radiopharmaceuticals today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying Primary Aldosteronism. |
| 2026-02-25 | Pentixapharm AG | Regulatory Pentixapharm Receives FDA “Study May Proceed” Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program pentixapharm.com ↗
U.S. Investigational New Drug (IND) applications for radiotheranostic pair PentixaFor and PentixaTher became active following completion of the FDA 30-day review period. |
| 2026-02-05 | Pentixapharm AG | Results Pentixapharm Announces Peer-Reviewed Phase 2 Data Back Use of PENTIXAFOR as a Superior Non-invasive PET-Diagnostic for Primary Aldosteronism pentixapharm.com ↗
Results published online show that [68Ga]Ga-Pentixafor PET/CT demonstrated high specificity and moderate sensitivity for identifying unilateral aldosterone-producing adenomas when compared with AVS and surgical outcomes. |
| 2025-10-06 | Pentixapharm AG | Results Pentixapharm Highlights Expanding CXCR4 Radiopharmaceutical Platform with New Clinical Findings at EANM 2025 pentixapharm.com ↗
The data demonstrate the high potential of [68Ga]Ga-PentixaFor to significantly improve subtyping of patients, thereby enabling better therapy decisions, and more precise patient management in PA. |
| 2024-10-18 | Pentixapharm AG | Regulatory EMA Grants PRIME Status to Pentixapharm’s Lead Candidate PentixaFor pentixapharm.com ↗
The European Medicine Agency (EMA) has granted PRIME Status to Pentixapharm’s lead candidate Ga68-PentixaFor, thereby granting an early and proactive support for the development of the radiodiagnostic and the possibility of an accelerated approval. |
| 2024-08-26 | Pentixapharm AG | Regulatory Pentixapharm AG Receives Orphan Drug Designation for its Radiodiagnostic Tracer PentixaFor in Marginal Zone Lymphoma by the European Medicines Agency pentixapharm.com ↗
the European Medicines Agency (EMA) and the European Commission (EC) have granted an Orphan Drug Designation for the diagnostic tracer PentixaFor, also known as Gallium (68Ga) boclatixafortide, for the diagnosis and staging of Marginal Zone Lymphoma. |
| 2024-06-25 | Pentixapharm AG | Regulatory Eckert & Ziegler Subsidiary Pentixapharm Receives Encouraging FDA Feedback to Initiate Phase III Trial with PentixaFor as Radiopharmaceutical Diagnostic in Primary Aldosteronism pentixapharm.com ↗ |
| 2022-11-25 | Pentixapharm AG | Regulatory Eckert & Ziegler Receives Green Light for Phase III Study with PENTIXAFOR pentixapharm.com ↗
PentixaPharm GmbH, a 100% subsidiary of Eckert & Ziegler AG (ISIN DE0005659700, SDAX), received green light from the European Medicines Agency (EMA) to conduct a phase III registration study in patients suffering from various forms of Non-Hodgkin-Lymphomas. |
| 2021-02-10 | Pentixapharm AG | Regulatory PENTIXAPHARM receives confirmation from EMA that its Lead Candidate PENTIXAFOR is ready for Phase III Study pentixapharm.com ↗
PentixaPharm, a radiopharmaceutical development company, received confirmation from the European Medicines Agency (EMA) last week that its lead candidate PentixaFor may be advanced directly in a phase III development program. |
All press releases naming this drug 20 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | (68)Ga-Pentixafor | “Thus our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis，differentiation and pretherapeutic evaluation of CXCR4 expression in lymphoma.” NCT03436342 ↗10“Chemokine receptor-4 targeted PET/CT with (68)Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to (18)F-FDG PET/CT.” PMID 31776631 ↗ Nov 2019 “68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor” NCT03335670 ↗ |
| Known as | [(68)Ga]Ga-Pentixafor | “Reduced splenic uptake of [(68)Ga]Ga-Pentixafor following first-line chemotherapy is associated with poor prognosis in patients with newly diagnosed multiple myeloma.” PMID 40540129 ↗ Jun 2025 |
| Known as | PentixaFor | “PentixaFor radiolabeled with 68Gallium (68Ga) is a radiopharmaceutical targeting the CXC chemokine receptor 4 (CXCR4) receptor.” NCT06478875 ↗ |
| Modality | Peptide | “68Ga Pentixafor is a radiolabeled cyclic pentapeptide” NCT03335670 ↗ |
| Route | Intravenous | “administered intravenously” NCT03335670 ↗ |
| Target | CXCR4 | “Chemokine receptor CXCR4 was expressed in MM and lymphoma cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique” NCT03436342 ↗ |