| Name | Molec Target | Isotope | ROA | Indication | Sponsor | Region | Trial Phase |
|---|
| AZD2265 | PSMA | 225Ac | IV | 2L PSMA+ mCRPC | AstraZeneca | EU | Phase 3 |
| AAA817 | PSMA | 225Ac | IV | Post-Lu (2L) mCRPC | Novartis | EU | Phase 2/3 |
| Actimab-A | CD33 | 225Ac | IV | R/R AML | Actinium Pharma | US | Phase 2/3 |
| RYZ101 | SSTR2 | 225Ac | IV | 2L+ SSTR2+ GEP-NETs | BMS | US | Phase 1b/3 |
| AlphaMedix | SSTRs | 212Pb | IV | GEP-NETs expressing SSTRs | Sanofi | US, EU | Phase 2 |
| CONV01-α | PSMA | 225Ac | IV | PSMA+ CRPC | Convergent Tx | US | Phase 2 |
| Radspherin | Non-targeting | 224Ra | IP | Ovarian / peritoneal cancer | Oncoinvent | EU | Phase 2 |
| RYZ801 | GPC3 | 225Ac | IV | GPC3+ HCC | BMS | US | Phase 1/2 |
| VMT-α-NET | SSTR2 | 212Pb | IV | SSTR2+ tumors | Perspective Tx | US | Phase 1/2a |
| VMT-01 | MC1R | 212Pb | IV | Advanced melanoma | Perspective Tx | US | Phase 1/2a |
| PSV359 | FAP-α | 212Pb | IV | FAP-α+ solid tumors | Perspective Tx | US | Phase 1/2a |
GEP-NET = gastroenteropancreatic neuroendocrine tumor; mCRPC/CRPC = metastatic/castration-resistant prostate cancer; AML = acute myeloid leukemia; HCC = hepatocellular carcinoma; IV = intravenous; IP = intraperitoneal; 2L = second-line.
Considering the assets above as well as assets in phase 1 of clinical trials outlined below, some key stats on the alpha-emitter landscape:
- Lead indications: Prostate cancer leads the pipeline with 8 assets in active development, followed by solid tumors (7 assets, spanning FAP-α, DLL3, Nectin-4, HER2, and GRPR targets), and GEP-NETs / neuroendocrine tumors (4 assets).
- Company and asset count by region: US - 13 assets across 7 companies. EU - 9 assets across 5 companies. Australia - 3 assets across 2 companies.
- Most Common Isotopes: Actinium-225 dominates the pipeline with 15 of 25 assets, followed by Lead-212 (8 assets). Radium-224 and Thorium-227 are each used in a single asset.
Pipeline Deep Dive
Below is a deep dive of global alpha-emitting radioligand therapy assets furthest along in clinical development:
1. AZD2265 (225Ac-PSMA) (AstraZeneca)
| Name(s) | AZD2265, zadavotide guraxetan, FPI-2265, 225Ac-PSMA-I&T |
| Molecular Target | prostate-specific membrane antigen (PSMA) |
| Radioactive Isotope | Actinium-225 (225Ac) |
| ROA | IV |
| Lead Indication | Second-line PSMA+ mCRPC[5][6] |
| Sponsor(s) | AstraZeneca (originally developed by Fusion Pharma, acquired by AZ in 2024)[7] |
| Sponsor Country | UK |
| Trial Name / NCT ID | VECTRA-01 (NCT07611110)[6] |
| Trial Phase | Phase 3 |
| Trial Design | Randomised Controlled |
Trial Progress / Other Milestones
- No clinical trial data is available from VECTRA-01, as the trial very recently registered and kicked off in Q2 2026.[8]
2. AAA817 (225Ac-PSMA) (Novartis)
| Name(s) | AAA817, 225Ac-PSMA-617, actinium (225Ac)-vipivotidum tetraxetan |
| Molecular Target | prostate-specific membrane antigen (PSMA) |
| Radioactive Isotope | Actinium-225 (225Ac) |
| ROA | IV[9] |
| Lead Indication | post-Lu (i.e., second-line) metastatic castration-resistant prostate cancer (mCRPC)[10] |
| Sponsor(s) | Novartis |
| Sponsor Country | Switzerland |
| Trial Name / NCT ID | PSMAcTION (NCT06780670)[11] |
| Trial Phase | Phase 2/3 |
| Trial Design | Open-label, International, Multicenter, Randomized |
Trial Progress / Other Milestones
- Being developed as the more targeted alpha therapy successor to Novartis's original RLT winner Pluvicto, AAA817 has entered pivotal phase 2/3 trials for metastatic prostate cancer. Novartis's lead indication and trial are targeting second-line treatment of the disease for patients that progress after first-line standard of care Pluvicto (PSMAcTION, NCT06780670)[11], as well as an additional trial (AcTFirst, NCT06855277) that tests the new therapy in the first-line setting.[9]
- While no recent trial updates have been provided, Novartis projects FDA regulatory filing for the therapy in 2028.[12]
3. Actimab-A (Actinium Pharma)
| Name(s) | 225Ac-lintuzumab, 225Ac-HuM195, Lintuzumab-Ac225 |
| Molecular Target | CD33[13] |
| Radioactive Isotope | Actinium-225 (225Ac) |
| ROA | IV |
| Lead Indication | Relapsed/refractory Acute myeloid leukemia (AML)[13] |
| Sponsor(s) | Actinium Pharmaceuticals |
| Sponsor Country | US |
| Trial Name / NCT ID | NA |
| Trial Phase | Phase 2/3 |
| Trial Design | NA |
Trial Progress / Other Milestones
- Recent press from Actinium Pharma indicates that Actimab-A is advancing towards a phase 2/3 trial.[14] However, no such trial is yet registered or kicked off, likely due to lack of available funding; Actinium lists on their pipeline that they are actively seeking a collaborator in order to move forward with this trial.[15]
- The therapy has multiple phase 1/2 trial failures and postponements which may be contributing to a stall in pivotal trial development: one study was completed in 2018 (NCT02575963)[16], another was withdrawn (NCT03932318)[17], and a final phase 1/2 trial records an unknown completion status (NCT03867682)[18].
4. RYZ101 (225Ac-DOTATATE) (Bristol Myers Squibb)
| Name(s) | RYZ101 |
| Molecular Target | somatostatin receptor 2 (SSTR2) |
| Radioactive Isotope | Actinium-225 (225Ac) |
| ROA | IV[19] |
| Lead Indication | 2L+ SSTR2+ Gastroenteropancreatic Neuroendocrine Tumors[20] |
| Sponsor(s) | Bristol Myers Squibb (BMS), RayzeBio (original developer, now a subsidiary of BMS following acquisition)[21] |
| Sponsor Country | US |
| Trial Name / NCT ID | ACTION-1 (NCT05477576)[22] |
| Trial Phase | Phase 1b/3 |
| Trial Design | Randomized, Controlled, Open-label |
Trial Progress / Other Milestones
- Most recent development updates came from a phase 1b portion readout of the ACTION-1 trial in 2024; the focus was on safety and dose-limiting toxicities, where the therapy was generally well-tolerated.[23][24] The phase 3 portion of the trial is still ongoing.
- BMS is pursuing additional oncology indications, namely SSTR+ HR+/HER2- unresectable metastatic breast cancer, through an ongoing phase 1 trial.[20]
5. AlphaMedix (212Pb-DOTAMTATE) (Sanofi)
| Name(s) | AlphaMedix, SAR447873, 212Pb-AR-RMX, ORM-2110 |
| Molecular Target | somatostatin receptors (SSTRs) |
| Radioactive Isotope | Lead-212 (212Pb) |
| ROA | IV[25] |
| Lead Indication | unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) expressing SSTRs[26] |
| Sponsor(s) | RadioMedix, Orano Med, Sanofi |
| Sponsor Country | US, France, France |
| Trial Name / NCT ID | ALPHAMEDIX02 (NCT05153772)[27] |
| Trial Phase | Phase 2 |
| Trial Design | open-label, multicenter, single-arm Phase 2 study |
Trial Progress / Other Milestones
- Most recently, phase 2 trial results were released in October 2025, highlighting promising overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) data.[26]
- Due to the FDA Breakthrough designation AlphaMedix received in 2024, these phase 2 trial results may be sufficient for pursuing accelerated approval in a high unmet need cancer population.[28]
- The single-arm trial design, as opposed to a dual-arm trial comparing AlphaMedix against standard of care, may lead to greater difficulty in using this phase 2 data to gain FDA approval.
6. CONV01-α (225Ac-PSMA) (Convergent Tx)
| Name(s) | CONV01-α, Ac-225 Rosopatamab Tetraxetan, Ac-225-J591 |
| Molecular Target | prostate-specific membrane antigen (PSMA) |
| Radioactive Isotope | Actinium-225 (225Ac) |
| ROA | IV |
| Lead Indication | PSMA+ Castration-Resistant Prostate Cancer (CRPC) |
| Sponsor(s) | Convergent Therapeutics |
| Sponsor Country | US |
| Trial Name / NCT ID | CONVERGE-01 (NCT06549465)[29] |
| Trial Phase | Phase 2 |
| Trial Design | Open-label study |
Trial Progress / Other Milestones
- Convergent recently shared interim data from the phase 2 CONVERGE-01 trial, highlighting radiographic PFS of 8.4 months and favorable tolerability.[30] Convergent signaled that phase 3 trial design was already underway due to promising interim phase 2 results.
7. Radspherin (Oncoinvent)
| Name(s) | Radspherin, 224Ra-CaCO₃-MP |
| Molecular Target | NA (therapy is non-targeting) |
| Radioactive Isotope | Radium-224 (224Ra) |
| ROA | intraperitoneal (IP) |
| Lead Indication | Advanced Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery[31] |
| Sponsor(s) | Oncoinvent Solutions AS |
| Sponsor Country | Norway |
| Trial Name / NCT ID | NCT06504147[31] |
| Trial Phase | Phase 2 |
| Trial Design | Randomised, Open Label |
Trial Progress / Other Milestones
- Radspherin is not an RLT, as it does not use a targeting ligand. Instead, it remains in the body cavity that it was injected into to create a radiation field,[32] yielding fewer oncology indications which may benefit from this therapy due to its non-targeting limitations.
- Oncoinvent achieved 50% recruitment in its phase 2 ovarian cancer trial as of June 2026.[33]
- Previous phase 1 and 1/2a trials in ovarian and colorectal cancer, respectively, were conducted, outlining favorable tolerability and leading to phase 2 advancement.[32] Both the ovarian and colorectal phase 1 trials achieved positive safety results, suggesting a separate rationale for the company pushing forward with ovarian cancer in a phase 2 trial.[34][35]
- FDA Fast Track designation was received in 2024.[36]
8. RYZ801 (225Ac-GPC3) (Bristol Myers Squibb)
| Name(s) | RYZ801 |
| Molecular Target | Glypican-3 (GPC3) |
| Radioactive Isotope | Actinium-225 (225Ac) |
| ROA | IV[37] |
| Lead Indication | GPC3+ unresectable hepatocellular carcinoma (HCC)[38] |
| Sponsor(s) | Bristol Myers Squibb (BMS), RayzeBio (original developer, now a subsidiary of BMS following acquisition)[21] |
| Sponsor Country | US |
| Trial Name / NCT ID | NCT06726161[38] |
| Trial Phase | Phase 1/2 |
| Trial Design | Randomized, Controlled, Open-label |
Trial Progress / Other Milestones
- The trial has recently begun and has yet to provide interim results. Most recent data on the therapy is preclinical.[39]
- RYZ801 has a companion diagnostic molecule, RYZ811.[38]
9. VMT-α-NET (203Pb-SSTR) (Perspective Tx)
| Name(s) | VMT-α-NET, bamzireotide navoxetan, [212Pb]VMT-Alpha-NET |
| Molecular Target | somatostatin receptor 2 (SSTR2) |
| Radioactive Isotope | Lead-212 (212Pb) |
| ROA | IV[40] |
| Lead Indication | unresectable or metastatic SSTR2-expressing tumors who have not received prior peptide receptor radionuclide therapy (PRRT)[40] |
| Sponsor(s) | Perspective Therapeutics (formerly known as Viewpoint Therapeutics)[41] |
| Sponsor Country | US |
| Trial Name / NCT ID | NCT05636618[40] |
| Trial Phase | Phase 1/2a |
| Trial Design | open-label, dose-finding/dose-expansion |
Trial Progress / Other Milestones
- Interim data from the ongoing phase 1/2a trial was presented at 2026 ASCO. Results primarily focused on primary safety endpoints indicating tolerability, but additional efficacy data based on an n=2 cohort 1 and n=23 cohort 2 patient population was also revealed. The key outcome included 39% of patients responding to treatment, with 7 patients experiencing a deepening of response as classified by investigators.[42]
- The therapy was granted FDA Fast Track designation in 2022 for treating patients with SSTR2-positive unresectable or metastatic neuroendocrine tumors.[43]
- Additional trials are being conducted, namely a phase 1 trial in PRRT-refractory neuroendocrine patients (NCT06148636).[44][45] The company also has its sights set on cancers beyond neuroendocrine tumors, such as meningioma, where SSTR2 is also quite relevant.[46]
- Like Perspective Therapeutics's other pipeline assets, the core technology is being developed not only as a treatment but also as a diagnostic, in this case utilizing a 203Pb isotope for imaging purposes.[45]
10. VMT-01 (212Pb-MC1R) (Perspective Tx)
| Name(s) | VMT-01, lead Pb 212-VMT01, Lapemelanotide zapixetar |
| Molecular Target | Melanocortin 1 receptor (MC1R) |
| Radioactive Isotope | Lead-212 (212Pb) |
| ROA | IV[47] |
| Lead Indication | Advanced Melanoma[47] |
| Sponsor(s) | Perspective Therapeutics (formerly known as Viewpoint Therapeutics)[41] |
| Sponsor Country | US |
| Trial Name / NCT ID | NCT05655312[47] |
| Trial Phase | Phase 1/2a |
| Trial Design | open-label dose-finding, dose-expansion |
Trial Progress / Other Milestones
- Most recent trial update outlined 27 patients enrolled as of late 2026, with 13 patients already having received treatment as either monotherapy or combination therapy.[48] For early interim data, 2 of the 7 patients receiving monotherapy doses showed partial responses.[48]
- Fast Track designation for treating advanced melanoma was received in 2024.[49]
- VMT-01 is listed in combination with VMT02; while VMT-01 is being developed both for imaging (203Pb) and treatment (212Pb), VMT02 is solely used for imaging (68Ga) to support subsequent treatment with VMT-01.[50]
11. PSV359 (212Pb-FAP-α) (Perspective Tx)
| Name(s) | PSV359, [212Pb]PSV359 |
| Molecular Target | FAP-α[51] |
| Radioactive Isotope | Lead-212 (212Pb) |
| ROA | IV[52] |
| Lead Indication | FAP-α positive solid tumors[51] |
| Sponsor(s) | Perspective Therapeutics (formerly known as Viewpoint Therapeutics)[41] |
| Sponsor Country | US |
| Trial Name / NCT ID | NCT06710756[52] |
| Trial Phase | Phase 1/2a |
| Trial Design | open-label dose-finding, dose-expansion |
Trial Progress / Other Milestones
- Perspective's most recent update on the phase 1/2a trial outlines 17 patients treated across the three trial cohorts. Interim trial results are expected in 2027.[48]
- The company also announced a collaboration with Merck for developing PSV359 as a combination therapy with pembrolizumab. This will be an amendment to the existing phase 1/2a study.[53]
Edge Case: Alpha DaRT (Alpha Tau Medical)
Alpha DaRT represents a set of devices designed to deliver an intratumoral injection of Radium-224.[54] Since the technology is a device platform, a cell-targeting ligand linked to the isotope is not necessary and it technically falls outside of the RLT landscape. It is, however, a directly competing radiopharmaceutical therapy and thus should be taken into consideration when assessing commercial opportunity by any RLT drug developer.
Phase 1 Assets in Development
There are numerous additional RLTs in earlier stages of development. Below are key assets which are in their first human clinical trials and farther out from any potential regulatory approval:
| Drug | Notes |
|---|
RYZ401 (225Ac-SSTR2) BMS / RayzeBio | Targeting somatostatin receptor 2 (SSTR2) along with an Actinium-225 isotope payload, RYZ401 is in an actively recruiting phase 1 trial (NCT07165132)[55] for patients with neuroendocrine tumors and other SSTR+ solid tumors. |
ESP359 (225Ac-DLL3) Novartis | Also known as [225Ac]Ac-ETN029, this therapy was originally developed by Mariana Oncology (former drug development code: MC-339).[56] ESP359 utilizes an Actinium-225 isotope and targets Delta-like canonical Notch ligand 3 (DLL3). It is currently in a phase 1 trial (NCT07006727)[57] for patients with advanced DLL3-positive solid tumors. |
TLX592-Tx (64Cu/225Ac-RADmAb) Telix Pharma | An early phase 1 trial (CUPID, NCT04726033)[58] was conducted evaluating safety in patients with prostate cancer. Telix states that a subsequent phase 1 trial (AlphaPRO) is expected to kick off within 2026.[59] |
TLX252-Tx (225Ac-CAIX) Telix Pharma | Also known as 225Ac-DOTA-girentuximab, this therapy is being developed for kidney cancer and has completed preclinical studies. The asset is poised for a phase 1 clinical trial kickoff (ALPHIX) within 2026.[59] |
BAY 2701439 (227Th-HER2) Bayer | Bayer has completed a phase 1 (NCT04147819)[60] safety trial for this therapy in patients with advanced cancers expressing HER2, although further developments have not been made clear since trial completion in late 2023. |
BAY 3563254 (225Ac-PSMA) Bayer | Also known as 225Ac-PSMA-Trillium, this therapy utilizes an Actinium-225 isotope and targets PSMA. The therapy is in an ongoing phase 1 study for mCRPC patients (PAnTHA, NCT06217822)[61] which, earlier in 2026, achieved successful dose expansion results.[62] |
LY4181530 (225Ac-PSMA) Eli Lilly | Originally developed by Point Biopharma (former drug development code: PNT2001), this therapy utilizes an Actinium-225 isotope and PSMA-62, a PSMA-targeting ligand.[63][64] LY4181530 is still being investigated in a phase 1 trial (ACCEL, NCT06229366).[65] |
LY4337713 (225Ac-FAP) Eli Lilly | Originally developed by Point Biopharma (former drug development code: PNT2004), this therapy utilizes an Actinium-225 isotope and a fibroblast activation protein (FAP)-targeting ligand. The molecule is in an active phase 1 trial (FiREBOLT, NCT07213791)[66] for treatment of various tumors with high levels of FAP expression. |
AKY-1189 (225Ac-Nectin-4) Aktis Oncology | Targeting Nectin-4 and carrying an Actinium-225 payload, AKY-1189 is in an active phase 1b trial (NECTINIUM-2, NCT07020117)[67] for patients with Nectin-4-positive solid tumors. Interim trial results are expected Q1 2027.[68] |
AKY-2519 (225Ac-B7-H3) Aktis Oncology | Targeting B7-H3 and carrying an Actinium-225 payload, AKY-2519 is Aktis Oncology's second leading asset. The therapy is in an active phase 1b trial (BActinium-1, NCT07581184)[69] for mCRPC, with preliminary data expected in 2027.[70] Aktis plans to initiate an additional phase 1b trial with a basket of indications including lung, colorectal, and other solid tumors, set to kick off H2 2026.[70] |
MP0712 (212Pb-DARPin-DLL3) Orano Med / Molecular Partners | Targeting DLL3 and carrying a Lead-212 isotope, this therapy very recently entered phase 1/2a clinical trials (NCT07278479).[71] |
212Pb-DOTAM-GRPR1 Orano Med | Targeting GRPR1 and carrying a Lead-212 payload, this therapy is in an active phase 1 trial (NCT05283330).[72] While details are less clear, Orano Med has an additional phase 1 asset, 212Pb-CEA-PRIT, for colorectal cancer in partnership with Roche.[73] |
ADVC001 (212Pb-PSMA) AdvanCell | This lead asset for AdvanCell targets PSMA and carries a Lead-212 isotope. It is currently being evaluated in a phase 1/2a trial (TheraPb, NCT05720130)[74] for treating metastatic prostate cancer.[75] |
Preclinical Assets in Development
Furthest out from market approval are the preclinical alpha-emitting RLTs. However, this early stage of the pipeline is full of development programs. Data is limited on these programs, as biotechs are increasingly not disclosing details of earlier-stage assets, largely for fear of rapid clinical development times in China that may cause a loss of first-to-market advantage.
| Drug | Notes |
|---|
ABD320 Abdera Therapeutics | In Q2 2025, Abdera presented preclinical data on ABD320, which targets 5T4/trophoblast glycoprotein and carries an Actinium-225 isotope. 5T4 is relevant for multiple cancers, including gastrointestinal, head and neck, and non-small cell lung cancer.[76] |
PSV594 Perspective Therapeutics | Targeting cholecystokinin 2 receptor (CCK2R) and carrying a Lead-212 isotope, PSV594 is poised to enter first-in-human clinical trials very soon. Perspective is planning a phase 1/2a trial and expects to provide additional details on timing in late 2026.[77] |
212Pb-PSMA Orano Med | While details are limited, Orano Med has a pre-IND asset targeting prostate cancer.[73] |
212Pb-DARPin-MSLN Orano Med / Molecular Partners | Following successful results seen with their phase 1 asset MP0712, the partnered biotechs are developing another DARPin-linked RLT, this time targeting mesothelin (MSLN).[73] |
RYZ701 RayzeBio | Targeting ACP3 with an unknown isotope payload (although, based on RayzeBio's other assets RYZ801 and RYZ401, it is likely Actinium-225), this asset is in IND-enabling stages and may enter human trials soon.[78] |
ADVC002 and ADVC003 AdvanCell | While disclosure is lacking on AdvanCell's website, the company appears to have additional assets beyond its lead, ADVC001. ADVC002 and ADVC003 appear to be discovery/preclinical-stage assets targeting melanoma and neuroendocrine tumors, respectively.[79][80] |
TLX102-Tx (211At-APA) Telix Pharma | This therapy is listed as targeting either or both L-type amino acid transporter 1 (LAT1) and glioblastoma multiforme (GBM) with an Astatine-211 isotope.[81] The asset has received FDA orphan drug designation for multiple myeloma and glioma, with Telix targeting leptomeningeal disease as the first target indication.[82] |
PSMA-5 (211At-PSMA) Osaka University | A publication was released in late 2025 outlining that efforts to scale up production of this alpha-emitting, PSMA-targeting RLT were underway to hopefully begin phase 1 clinical trials.[83][84] |
Note: Across preclinical and clinical phases 1-3, there are likely additional alpha-emitting assets in global development that weren't captured in this report. While we aim to be as comprehensive as possible, our goal is to focus on the most notable assets that will shape the treatment landscape, and no claims of 100% coverage are made.
Paused or Discontinued Programs
Below are some notable asset development programs that were either paused or permanently discontinued.
| Drug | Notes |
|---|
FPI-1434 (225Ac-IGF-1R) AstraZeneca / Fusion Pharma | Targeting Insulin-like Growth Factor 1 Receptor (IGF-1R) using an Actinium-225 isotope, FPI-1434 was in a phase 1 trial (NCT03746431)[85] which appears to have been terminated.[86] The trial was likely paused due to prioritization of other RLT assets, namely AZ's phase 3 asset AZD2265/FPI-2265 outlined above. |
FPI-2059 (225Ac-NTSR1) AstraZeneca / Fusion Pharma | Targeting neurotensin receptor 1 (NTSR1) using an Actinium-225 isotope, FPI-2059 was in a phase 1 trial (NCT05605522)[87] that was terminated due to portfolio prioritization decisions, as outlined by AZ.[88] |
FPI-1966 (225Ac-FGFR3) AstraZeneca / Fusion Pharma | This therapy, aimed at treating FGFR3-expressing solid tumors, was in a phase 1/2 trial (NCT05363605)[89] that was terminated due to prioritization of other RLT therapies in the Fusion Pharma portfolio. |
ABD-147 (225Ac-DLL3) Abdera Therapeutics | While the company presented phase 1 clinical data as recently as September 2025 for patients with small cell lung cancer and large cell neuroendocrine carcinoma, Abdera appears to have gone out of business, and ABD-147 along with it.[90][91] The asset does not appear to have been continued by Abdera's original partner, AbCellera Therapeutics, as it is absent from their active clinical pipeline.[92] |
CD33-TTC Bayer | While this CD33-targeting Thorium-227 isotope therapy appeared to be in preclinical development as of 2016, there are no indications that it progressed into clinical trials afterward, suggesting the molecule was abandoned for other pursuits.[93] |
225Ac-SS0110 Ariceum Therapeutics | While the asset was in full swing in a phase 1/2 trial (NCT06939036)[94], the study is listed on clinicaltrials.gov as having been terminated due to strategic business decisions.[95] |
The targeted alpha therapy landscape is nearing a first-in-class approval, as multiple assets are in phases 2/3 of clinical trials. Many assets carry breakthrough designations for oncology indications that would let them file for regulatory approval without an expansive global phase 3 effort.
Novartis currently owns the RLT space, with ownership over both therapies currently on the market. Since these are beta-emitters, they also have alpha-emitting assets in the pipeline to compete for this new market. Sanofi, AstraZeneca, and BMS are three of the other big pharma contenders in this space with late clinical-stage assets (Eli Lilly has also made an acquisition to get into the game, but its assets are in earlier phase 1 stages).
Two key emerging biotech players to keep an eye on are Perspective Therapeutics and Telix Pharma. Both companies have numerous assets in the pipeline and are RLT-focused, hoping to carve out a good chunk of this market.
One notable absence is the lack of China-based biotech companies pursuing this space. While there seem to be a couple of Chinese biotechs working on TATs, the number is quite low. There appear to be more Chinese biotechs developing beta-emitters, which is an older and more developed market.
Alpha-emitting RLTs hold the promise for highly targeted and efficacious radiation treatment of many different malignancies. Time will tell if these treatments become a core component of standard of care in oncology.