Key findings
- ClinicalTrials.gov lists 577 1 interventional studies of therapeutic radioisotopes; 323 2 are active and 51 3 are Phase 3.
- 291 4 started between January 2023 and September 2026: 127 5 with a US site and 75 6 with a China site.
- Lutetium-177 agents appear in 222 7 of the new studies and actinium-225 agents in 48 8.
- Prostate cancer is the leading indication, with 145 9 new studies.
Momentum: steady growth after Pluvicto
Trial starts rose from 36 10 in 2020 to 79 11 in 2025, with the step up coming in 2022 (50 12) and 2023 (67 13), after the FDA approved Pluvicto in March 2022.
The United States is the centre of the field. Studies with a US site went from 17 14 in 2020 to 39 15 in 2025. China started from a low base, 2 16 studies in 2020, and reached 22 17 in 2025. Growth there is led by academic nuclear medicine centres, such as Peking Union Medical College Hospital, and by domestic companies building isotope supply.
Radioligand trial starts doubled between 2020 and 2025
Interventional radioligand therapy studies by start year; a study with sites in both countries counts in both lines
View the underlying data
| Series | Period | Type | Value |
|---|---|---|---|
| All studies | 2025 | Actual | 79 |
| All studies | 2024 | Actual | 79 |
| All studies | 2023 | Actual | 67 |
| All studies | 2022 | Actual | 50 |
| All studies | 2021 | Actual | 31 |
| All studies | 2020 | Actual | 36 |
| With a US site | 2025 | Actual | 39 |
| With a US site | 2024 | Actual | 37 |
| With a US site | 2023 | Actual | 24 |
| With a US site | 2022 | Actual | 27 |
| With a US site | 2021 | Actual | 15 |
| With a US site | 2020 | Actual | 17 |
| With a China site | 2025 | Actual | 22 |
| With a China site | 2024 | Actual | 19 |
| With a China site | 2023 | Actual | 18 |
| With a China site | 2022 | Actual | 9 |
| With a China site | 2021 | Actual | 6 |
| With a China site | 2020 | Actual | 2 |
Live registry counts retrieved 2026-09-27. Studies registered only outside ClinicalTrials.gov, including many China-only trials, are not counted.
Isotopes and targets
Lutetium-177, a beta emitter, appears in 222 7 studies started since 2023. PSMA-targeted radioligands appear in 98 28 and somatostatin-receptor-targeted agents in 45 29.
Alpha emitters are the main technical shift. They deliver much more energy over a shorter range, which may overcome resistance to beta emitters. Actinium-225 agents appear in 48 8 new studies and lead-212 agents in 11 30. Radium-223, the first approved alpha therapy, appears in 8 31, a sign that its label-expansion phase is largely over.
New targets are moving in behind PSMA and SSTR: FAP (fibroblast activation protein), GRPR, CA9 in kidney cancer, and HER2. Most are still in Phase 1.
Lutetium-177 leads new trials, with alpha emitters growing
Interventional studies started since January 2023, by asset or class; a study can count in more than one bar
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| Lutetium-177 agents | ClinicalTrials.gov | Actual | 222 |
| PSMA-targeted | ClinicalTrials.gov | Actual | 98 |
| Actinium-225 agents (alpha) | ClinicalTrials.gov | Actual | 48 |
| Somatostatin-receptor-targeted | ClinicalTrials.gov | Actual | 45 |
| Lead-212 agents (alpha) | ClinicalTrials.gov | Actual | 11 |
| Radium-223 | ClinicalTrials.gov | Actual | 8 |
Live registry counts retrieved 2026-09-27. Name and code matching can miss studies registered under other identifiers.
Indications: prostate first, neuroendocrine second
Prostate cancer is listed in 145 9 radioligand studies started since 2023, and neuroendocrine tumours in 49 32. Breast cancer (25 33), lung cancer (25 34) and kidney cancer (13 35) are much smaller but are where new-target programmes are heading.
In prostate cancer, the trials are moving earlier in the disease: before chemotherapy, in hormone-sensitive disease, and in oligometastatic disease. Those are larger markets but also need longer and more expensive trials.
Prostate cancer accounts for about half of new radioligand trials
Interventional studies started since January 2023, by condition; a study can count in more than one bar
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| Prostate cancer | ClinicalTrials.gov | Actual | 145 |
| Neuroendocrine tumours | ClinicalTrials.gov | Actual | 49 |
| Breast cancer | ClinicalTrials.gov | Actual | 25 |
| Lung cancer | ClinicalTrials.gov | Actual | 25 |
| Kidney cancer | ClinicalTrials.gov | Actual | 13 |
Live registry counts retrieved 2026-09-27. Name and code matching can miss studies registered under other identifiers.
Approvals and consolidation
- Pluvicto (lutetium Lu 177 vipivotide tetraxetan, PSMA), approved 23 March 2022 (NDA 215833)
- Lutathera (lutetium Lu 177 dotatate, SSTR), 26 January 2018 (NDA 208700)
- Xofigo (radium Ra 223 dichloride), 15 May 2013 (NDA 203971)
Large companies bought their way in. Novartis acquired Advanced Accelerator Applications (Novartis) and Endocyte in 2018. Eli Lilly acquired POINT Biopharma in December 2023, Bristol Myers Squibb completed its RayzeBio acquisition in February 2024 (BMS), and AstraZeneca acquired Fusion Pharmaceuticals in June 2024. AstraZeneca's actinium-225 PSMA agent and Novartis's actinium-225 version of PSMA-617 are now in Phase 3 in prostate cancer.
What it means for founders and R&D teams
- Isotope supply is a strategic asset. Actinium-225 and lead-212 are scarce. Companies that control production, generators or manufacturing slots have leverage that a new ligand alone does not.
- New targets beat new PSMA ligands. PSMA already has an approved drug and two alpha-emitter Phase 3 programmes. FAP, CA9, GRPR, DLL3 and other targets have open space, but need proof that tumour uptake is high and kidney and salivary exposure is low.
- Pair diagnostics with therapeutics. A matching imaging agent selects patients and can generate revenue earlier.
- Logistics decide commercial success. Short half-lives mean that site networks, dosimetry and nuclear medicine capacity limit how fast a product can grow. China's expanding nuclear medicine infrastructure is an opportunity for regional players.
Methodology and limitations
Every trial count is the totalCount of one ClinicalTrials.gov API v2 query, retrieved on 26 September 2026. Each numbered citation opens a record whose source link re-runs the query. The track includes interventional studies whose interventions name lutetium-177, actinium-225, lead-212, radium-223, terbium or copper-67, or radioligand therapy. Iodine-131 and imaging-only agents are excluded, but some included studies also use imaging tracers.
Site-country counts overlap and China-only registrations are missing. Isotope and target bars match intervention text and can overlap. Approval dates come from Drugs@FDA. Acquisitions and programme stages are based on company announcements.
Approved, Phase 3 and Phase 2 drugs
The named drugs in this report by their furthest stage: US approval from Drugs@FDA, phase from ClinicalTrials.gov. Sort any column or download CSV; each date and trial number links to its source.
| Drug | Stage | First FDA approval | Latest trial at that stage | Trial start | Trial |
|---|---|---|---|---|---|
| Lutetium Lu 177 dotatate (SSTR) | Approved | 26 Jan 2018 Bexlutry, Lutathera · NDA 208700 | NCT07057622 Phase 3 · Recruiting | 12 Dec 2023 | A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs |
| Lutetium Lu 177 vipivotide tetraxetan (PSMA) | Approved | 23 Mar 2022 Pluvicto · NDA 215833 | NCT06496581 Phase 3 · Recruiting | 12 Sep 2024 | Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) |
| Radium Ra 223 dichloride | Approved | 15 May 2013 Xofigo · NDA 203971 | NCT04237584 Phase 3 · Terminated | 30 Jun 2020 | A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients |
| 177Lu-PNT2002 (PSMA) | Phase 3 | Not checked: development code, no approved name | NCT04647526 Phase 3 · Active, not recruiting | 25 Feb 2021 | Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment |
| 225Ac-PSMA-617 / AAA817 (PSMA, alpha) | Phase 3 | Not checked: development code, no approved name | NCT06855277 Phase 3 · Recruiting | 1 Jul 2025 | Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC |
| FPI-2265 (225Ac-PSMA I&T, alpha) | Phase 3 | Not checked: development code, no approved name | NCT07611110 Phase 3 · Recruiting | 4 May 2026 | AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) |
| Lutetium Lu 177 edotreotide / ITM-11 (SSTR) | Phase 3 | Not FDA approved | NCT04919226 Phase 3 · Active, not recruiting | 21 Dec 2021 | Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE |
| RYZ101 (225Ac-DOTATATE, alpha) | Phase 3 | Not checked: development code, no approved name | NCT05477576 Phase 3 · Recruiting | 24 Mar 2022 | Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy |
| 212Pb-DOTAMTATE / AlphaMedix (SSTR, alpha) | Phase 2 | Not checked: development code, no approved name | NCT05153772 Phase 2 · Active, not recruiting | 21 Dec 2021 | Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients |
How this report is checked
Every figure is a count from ClinicalTrials.gov, the US National Library of Medicine's trial registry. Each links to a StatOrigin record that keeps the exact query, so anyone can run it again; how the counts are made and what they leave out is set out under Methodology and limitations above.
The development-stage table
Checked on 4 October 2026. A drug's US approval is the original approval of its first new drug application or biologics licence application in Drugs@FDA, read through the FDA's openFDA service, with the FDA approval letter where Drugs@FDA links one. Cell and gene therapies are licensed by a different FDA centre (CBER) and are not in Drugs@FDA; an approval for one of them is shown only where it was checked by hand against the FDA's product page. Approvals outside the United States — by the European Medicines Agency or China's NMPA, for example — are not shown. The phase is the highest phase among the drug's interventional ClinicalTrials.gov records. The trial shown is the most recently started one at that phase whose title names the drug, or, where none does, the most recently started one that lists it.
Writing and review
Written by StatOrigin editorial with AI assistance. Each count is checked automatically against the registry's own response before it is published. No named clinical reviewer has checked this report yet. Report an error through the corrections page.
Not medical advice
This report describes research activity and regulatory status. It is not medical advice and does not say whether any medicine is safe or effective for any person. Trial activity is not evidence that a drug works. Decisions about treatment belong with a qualified health professional; for what a medicine is approved to treat, read its current FDA label.
Data behind this report
The industry hubs and indicator series these figures come from. Each page carries the full table, every source and the records this report does not quote.
Industry hubs
Indicator series
- Radioligand therapy trial starts 21
- Active radioligand therapy trials 1
- Phase 3 radioligand therapy trials 1
- Radioligand therapy trial starts since 2023: Breast cancer 1
- Radioligand therapy trial starts since 2023: Kidney cancer 1
- Radioligand therapy trial starts since 2023: Lung cancer 1
- Radioligand therapy trial starts since 2023: Neuroendocrine tumours 1
- Radioligand therapy trial starts since 2023: Prostate cancer 1
- Registered interventional radioligand therapy trials 1
- Trial starts since 2023: Actinium-225 agents (alpha) 1
- Trial starts since 2023: Lead-212 agents (alpha) 1
- Trial starts since 2023: Lutetium-177 agents 1
- Trial starts since 2023: PSMA-targeted 1
- Trial starts since 2023: Radium-223 1
- Trial starts since 2023: Somatostatin-receptor-targeted 1
Sources
Every figure in this report is a published StatOrigin record. The table lists the 35 cited statistics. Sort any column or download CSV. Open a record for APA, MLA, Chicago or BibTeX.
Cite this report
StatOrigin. (2026). Radioligand therapy: from lutetium-177 to alpha emitters. https://statorigin.org/reports/radioligand-therapy-pipeline-2026
Prefer citing the underlying statistic when you only need one figure. Published 26 September 2026 · updated 27 September 2026. Data licence: CC BY 4.0.