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Radiopharmaceuticals: radioactive isotopes used as warheads aimed precisely at tumours.

Radiopharmaceuticals
7Tracked assets
0Approved

How this track works

Radioligand therapy attaches a radioactive isotope to a small molecule or peptide that recognises the tumour, so radiation is released at close range once the drug arrives. The success of Pluvicto and Lutathera set off a wave of big-pharma acquisitions of radiopharma companies. Isotope supply, manufacturing and distribution networks are the key barriers in this field.

Development stage

Registration11
Phase 333
Phase 211
Phase 1/211
Phase 111

Origin country / region

South Korea22
China44
Japan11

Assets

RankAssetINNOriginatorCountryTargetsMechanismHighest stageIndicationTrial IDsOverseas rights holderDeal dateUpfrontTotal ceilingLatest eventLatest event dateSourcesSource date
1Lu-177-DGUL (pocubotide)pocubotide (per Korean press; INN spelling not confirmed on WHO list)Cellbion Co., Ltd.South KoreaPSMA177Lu-labelled small-molecule PSMA radioligand (beta emitter); theranostic pair with Ga-68-NGULRegistration — South Korea (MFDS conditional approval filed 2025-12-30; under review)PSMA-positive mCRPC refractory to standard therapy; Ph3 vs SOC approved; Ph1 combo with pembrolizumabNCT05547061None reported (partnering talks reported, no signed deal)———MFDS approved Phase 3 IND (150 pts, 1:1 vs standard care) in mCRPC; conditional approval decision still pending2026-09-291 2 3 2026-09-29
2FC705 ([177Lu]Ludotadipep)ludotadipepFutureChem Co., Ltd.South KoreaPSMA177Lu-labelled small-molecule PSMA radioligand (beta emitter)Phase 3 — South Korea (2026-01)mCRPC (Ph3 Korea, rPFS by BICR); Ph2a in USNCT07853209 | NCT04509557 | NCT05579184None reported for FC705 (FutureChem's China/Europe deals cover diagnostic FC303 only)———Randomized Phase 3 in mCRPC (started 2026-01-26) registered on ClinicalTrials.gov2026-10-011 2 2026-10-01
3HRS-4357—Jiangsu Hengrui PharmaceuticalsChinaPSMA177Lu-labelled PSMA-targeted radioligand (beta emitter)Phase 3 — China (2026-02)PSMA-positive progressive mCRPC vs switch of ARPI (Ph3, n=370); advanced prostate cancer (Ph1/2)NCT07311694 | NCT06006104None reported———Phase 3 vs novel ARPI in PSMA-positive mCRPC started enrolling2026-02-021 2 3 2026-02-04
4177Lu-NYM032—Norroy Bioscience (Wuxi Nuoyu Pharmaceutical Technology)ChinaPSMA177Lu-labelled small-molecule PSMA radioligand; theranostic pair with 68Ga-NYM032 (same precursor)Phase 3 — China (NMPA-cleared; registered 2026-08, not yet recruiting)Progressive PSMA-positive mCRPC vs best standard of care (Ph3, OS endpoint); mCRPC (Ph1/2)NCT07795268 | NCT06383052None reported———Norroy announced NMPA clearance for pivotal Phase 3 of 177Lu-NYM032 in mCRPC2026-09-021 2 3 4 2026-09-03
5177Lu-LNC1011—Yantai Lannacheng Biotechnology (LNC; Dongcheng Pharmaceutical subsidiary)ChinaPSMA177Lu-labelled small-molecule PSMA ligand (dansyl-modified PSMA ligand)Phase 2 — China (Ph1/2; Ph2 enrollment completed 2026-01)PSMA-positive mCRPC; Ph3 planned 1H 2027; 225Ac-LNC1011 follow-on in Ph1/2NCT06250244 (IIT) | NCT06377683 (IIT)None reported———LNC re-filed Hong Kong IPO application disclosing Ph2 enrollment completed (Jan 2026) and Ph3 planned for 1H 20272026-06-121 2 3 2026-09-10
6TRC003—C Ray Therapeutics (Chengdu) Co., Ltd.ChinaPSMA225Ac-labelled PSMA-targeted radiopharmaceutical (alpha emitter)Phase 1/2 — China (2026-05)Progressive PSMA-positive mCRPC after ARPI or taxane (randomized 3-dose Ph1/2, n=90)NCT07567521None reported———Randomized Phase 1/2 in PSMA-positive mCRPC started2026-05-221 2 2026-05-29
7PD-32766T (225Ac-PD-32766)—PeptiDream Inc.JapanCA9 (carbonic anhydrase IX)225Ac-labelled macrocyclic peptide (alpha emitter); theranostic pair with 64Cu-PD-32766DPhase 1 — US (2026-07)Relapsed/refractory CA9-positive clear cell renal cell carcinomaNCT07688187None reported (in-house PeptiDream / PDRadiopharma discovery)———Phase 1a/1b theranostic study (64Cu-PD-32766D imaging + 225Ac-PD-32766T therapy) started in the US2026-07-071 2 2026-09-18

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