Since June 2024, a randomized, investigator-initiated Phase 3 clinical trial of 64Cu-ATSM is conducted in Japan. Through a partnership with LinqMed, PDRadiopharma will be responsible for the regulatory submission and commercialization of 64Cu-ATSM.
Strategic Alliance
Indication: Malignant brain tumors
Mechanism of action: Localize to hypoxi tumor microenvironments and deliver therapeutic radionucleotide
Modality: small molecule
Origin: LinqMed
Press Release
2024/6/25 (LinqMed release) LinqMed issues press release on the safety and efficacy of 64Cu-ATSM, a novel radiotherapy for the treatment of recurrent and refractory malignant brain tumors, and announces the initiation of a Phase3 comparative study in preparation for application for accelerated approval (Japanese only)
2023/12/22 PeptiDream and LinqMed Announce Strategic Partnership for the Development and Commercialization of 64Cu-ATSM in Japan
・Potential Market Opportunity
| Number of Patients |
Market Size |
Key Product Sales (Global) |
Incidence 321,731
(global, 2020)(1) |
$4.4bn
(global, 2031)(2) |
|
- Number of Patients
- Incidence 321,731
(global, 2020)(1)
- Market Size
- $4.4bn
(global, 2030)(2)
- Key Product Sales (Global)
Source: (1) WHO the global cancer observatory (2) Research and Markets
Through a partnership with Curium, PDRadiopharma and Curium will jointly collaborate on domestic development of 177Lu-PSMA I&T and 64Cu-PSMA I&T. PDRadiopharma will lead the regulatory submission, manufacturing, and commercialization.
Curium has ccuurelyompleted a Phase 3 clinical trial outside Japan. In Japan, a clinical trial required for regulatory approval is currently underway, with the aim of submitting a new drug application (NDA) in 2029.
onducting a Phase 3 clinical trial outside Japan. In Japan, a clinical trial required for regulatory approval is also underway, with the aim of submitting an NDA in 2027.
Strategic Alliance
Indication: Prostate cancer
Mechanism of action: peptide-radioisotope conjugate against PSMA
Modality: Small molecule
Origin: Curium
Press Release
Clinical trial information
Global Trial
Domestic Trial
Potential Market Opportunity
| Number of Patients |
Market Size |
Key Product Sales (Global) |
Incidence 1,467,854
(global, 2020)(1) |
$23.1bn
(global, 2030)(2) |
Pluvicto®
$1,392m (2024)(3) |
- Number of Patients
- Incidence 1,467,854
(global, 2020)(1)
- Market Size
- $23.1bn
(global, 2030)(2)
- Key Product Sales (Global)
- Pluvicto®
$1,392m (2024)(3)
Source: (1) WHO the global cancer observatory (2) Grand View Research (3) Evaluate
RayzeBio is currently conducting a Phase 1/1b clinical trial in the United States. PeptiDream has an option right for development and commercialization in Japan while RayzeBio holds the global rights for development and commercialization.
Strategic Alliance
- Indication: Liver Cancer
- Mechanism of acction: peptide-radioisotpe conjugate against Glypican-3
- Modality: RI-PDC
- Origin: PeptiDream
Press Releases
2025/1/28 PeptiDream Announces Initiation of Phase1/1b Clinical Trial of RYZ801/RYZ811
2023/9/19 PeptiDream Announces Initial Public Offering of RayzeBio and Update on GPC3 Program
2023/3/22 PeptiDream Announces Nomination of Second Peptide Radiopharmaceutical Therapeutic Development Candidate
2020/8/4 PeptiDream Announces Strategic Partnership with RayzeBio for the Discovery and Development of Peptide-Radiotherapeutics
Clinical Trials Information
Study of the Theranostic Pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to Identify and Treat Subjects with GPC3+ Unresectable HCC (GPC3)
・Potential Market Opportunity
| Number of Patients |
Market Size |
Key Product Sales (Global) |
Incidence 866,136
(global, 2022)(1) |
$5.3bn
(8MM, 2029)(2) |
Lenvima®
$653m (2024)(3) |
- Number of Patients
- Incidence 866,136
(global, 2022)(1)
- Market Size
- $5.3bn
(8MM, 2029)(2)
- Key Product Sales (Global)
- Lenvima®
$653m (2024)(3)
Note: 8MM: US, Japan, UK, Germany, France, Italy, Spain, China
Source: (1) Global Observatory, (2) GlobalData, (3) Evaluate
In-house Program
- Indication: Renal cell carcinoma (RCC)
- Mechanism of action: peptide-radioisotope conjugate against CAIX
- Modality: RI-PDC
- Origin: PeptiDream
225Ac-PD-32766 and 64Cu-PD-32766 are theranostic agents that target carbonic anhydrase IX (CA9), a tumor-associated antigen highly expressed in clear cell renal cell carcinoma.
The IND application has been cleared by the U.S. Food and Drug Administration (FDA), and a Phase 1 clinical trial is planned to be conducted in the United States.
Press Releases
2025/12/22 PeptiDream Announces FDA Clearance of IND Applications for Phase 1 Clinical Trials of 225Ac-PD-32766 and 64Cu-PD-32766 in Patients with Kidney Cancer
2025/3/28 New Radiopharmaceuticals for Renal Cell Carcinoma
2024/6/4 NCC and PeptiDream Announce the First Dosing of 64Cu-PD-32766 in a patient with Clear Cell Renal Cell Carcinoma
2023/11/27 Collaboration with National Cancer Center Japan to Accelerate Development of CAIX-Targeting Radiopharmaceutical Program
2023/11/1 PeptiDream Announces First Internal Peptide Radiopharmaceutical Therapeutic Program
Potential Market Opportunity
Number of Patients
（year） |
Market Size
（year） |
Key Product Sales
（year） |
431,288
(global, 2020)(1) |
$1.0bn
(global, 2029)(2) |
Cabometyx
$1,776mn (2024)(3) |
- Number of Patients
（year）
- 431,288
(global, 2020)(1)
- Market Size
（year）
- $1.0bn
(global, 2029)(2)
- Key Product Sales
（year）
- Cabometyx
$1,776mn (2024)(3)
Source: (1) Eur. Urol. 82 529-542 (2) Data Bridge (3) Evaluate
Collaboration Research
- Indication: Cancer
- Modality: RI-PDC
- Origin: PeptiDream
2024/7/30 The program has entered into IND-enabling studies.
In-house Program
- Indication: Gastric Cancer
- Mechanism of action: peptide-radioisotope conjugate against Claudin 18.2
- Modality: RI-PDC
- Origin: PeptiDream
Press Releases
2024/12/12 PeptiDream Announces Second Internal Peptide Radiopharmaceutical Therapeutic Program Targeting Claudin 18.2 for the Potential Diagnosis and Treatment of Gastric Cancer
・Potential Market Opportunity
| Number of Patients |
Market Size |
Key Product Sales (Global) |
Incidence 968,784
(global, 2022)(1) |
$10.8bn
(Global, 2030)(2) |
Opdivo®
$1,256m (2024)(3) |
- Number of Patients
- Incidence 968,784
(global, 2025)(1)
- Market Size
- $10.8bn
(Global, 2030)(2)
- Key Product Sales (Global)
- Oprivo®
$1,256m (2024)(3)
Note: (3) Sales for Gastric Cancer
Source: (1) Global Observatory, (2) Grand View Research, (3) Evaluate
Discovery and Development Collaboration
・Indication：Oncology
・Mechanism of action：PD-L1 targeting PET tracer
・Modality：Diagnostic RI-PDC
・Origin: PeptiDream
BMS-986229 originated from our drug discovery collaboration with Bristol-Myers Squibb to develop a radiopharmaceutical
diagnostic agent to evaluate PD-1/PD-L1 expression in patients. BMS-986229 is an 18F-labeled, peptide-based PET tracer
that specifically binds to cancer cells expressing PD-L1 and is expected to be used to determine the use of checkpoint
inhibitor therapy to cancer patients.18F-BMS-986229 recently completed a Phase 1 observation study, conducted at Memorial Sloan Kettering Cancer Center. The Phase 1 study met both its primary safety and feasibility endpoints.
・Press Release
2018/2/15 PeptiDream Announces Initiation of a Molecular Imaging Study in Discovery Alliance with Bristol-Myers Squibb
・Clinical trial information
NCT04161781
・Indication：Acromegaly
・Mechanism of Action：Growth hormone receptor antagonist
・Modality：Therapeutic peptide
・Origin：PeptiDream
In September 2021, the compound was licensed out to Amolyt Pharma as a therapeutic peptide candidate for the treatment of acromegaly, and development has since been advanced by Amolyt Pharma under the name AZP-3813.
Amolyt Pharma has completed a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of AZP-3813 in healthy volunteers, in which a favorable safety and tolerability profile was confirmed.
A Phase 2 clinical trial in adult patients was initiated in November 2025.
・Press release
2025/11/26 PeptiDream Receives Milestone Payment Upon Initiation of Phase 2
Clinical Trial for ALXN2420 in Patients with Acromegaly
2024/7/10 PeptiDream Provides Update on the Phase 1 Clinical Study of Growth Hormone Receptor Antagonist Program
2021/9/9 Amolyt Pharma Exercises Option to License Optimized Acromegaly Drug Candidate from PeptiDream as it Continues to Build its Rare Endocrine Pipeline (Press Release)
2020/12/8 PeptiDream Announces Strategic Partnership and License Option Agreement with Amolyt Pharma (Press Release)
Potential market opportunity (acromegaly)
| Number of Patients |
Market Size |
Key Product Sales (Global) |
56,000 people
(global, 2022)(1) |
$1.3bn USD
(Global, 2021)(2) |
Somavert®
$256mn (2024)(3) |
- Number of Patients
- 56,000 people
(global, 2022)(1)
- Market Size
- $1.3bn USD
(Global, 2021)(2)
- Key Product Sales (Global)
- Somavert®
$256mn (2024)(3)
Source: (1) Grand View Research (2) Databridge (3) Evaluate
Biohaven has completed a Phase 1a/1b trial in the US.
Strategic Alliance
・Indication：Multiple myeloma
・Mechanism of action：CD38 and immunoglobulin-targeting bispecific agent
・Modality：Therapeutic MPC
・Origin: PeptiDream
BHV-1100 is the lead program from PeptiDream’s strategic alliance with Biohaven and is a bifunctional compound which
includes a CD38-binding peptide identified by PeptiDream and Biohaven’s Antibody Recruiting Molecule (ARMTM). Since
October 2021, Biohaven is conducting a Phase 1a/1b trial of BHV-1100 in combination with autologous NK cells(1) to
evaluate the safety, tolerability, and exploratory efficacy of BHV-1100 in multiple myeloma patients in first or second remission who have minimal residual disease (MRD+). On September 2020, the US FDA granted Orphan Drug designation to BHV-1100 for the treatment of multiple myeloma.
・Reference
Biohaven pipeline：Pipeline | Biohaven
CD-38 program：CD-38: ARM™ - Next Generation Bispecific Molecules (biohaven.com)
ARM™ platform technology：ARM™ - Next Generation Bispecific Molecules (biohaven.com)
・Clinical trial information
NCT04634435
・Potential Market Opportunity
| Number of Patients |
Market Size |
Key Product Sales (Global) |
New cases 187,952
(Global, 2022)(2) |
$31.0bn
(Global, 2026)(3) |
Darzalex®
$11.6bn (2024)(4) |
- Number of Patients
- New cases 187,952
(Global, 2022)(2)
- Market Size
- $31.0bn
(Global, 2026)(2)
- Key Product Sales (Global)
- Darzalex®
$11.6bn (2024)(3)
Notes: (1) NK cells: Natural killer cells
Source: (2) WHO the global cancer observatory, (3) Fortune Business Insights, (4) Evaluate
PeptideAid has completed a Phase 1 clinical trial in healthy volunteers in the United States, in which favorable safety, tolerability, and pharmacokinetic results were obtained.
Affiliate Program
・Indication：COVID-19
・Mechanism of action：SARS-CoV-2 Spike protein S2 inhibitor
・Modality：Therapeutic peptide
・Origin: PeptiDream
Our affiliate company, PeptiAID Inc. is developing PA-001, a peptide-based inhibitor targeting the S2 domain of the
SARS-CoV-2 spike protein, a protein essential for coronavirus entry into human cells. The S2 region is highly conserved
across variants and subvariants, and PA-001 demonstrated potent activity against all major variants from Wuhan to
Omicron BA.5. A single ascending dose study of PA-001 in healthy subjects in Japan was completed and confirmed a
favorable safety profile. In July 2024, PeptiAID received clearance to initiate a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of PA-001 in healthy elderly volunteers. PA-001 was adopted by the Japan Agency for Medical Research and Development (AMED) as part of the “Research Program on Emerging and Re-emerging Infectious Diseases” (Project Name: Pre-clinical and Phase 1 studies of PA-001 to pursue treatment agent for COVID-19) and received funding support from AMED to conduct clinical development activities.
・Press Release
2025/9/30 PeptiDream Affiliated Company, PeptiAID Inc., Announces Completion of Phase 1 Clinical Trial of PA-001
2025/6/16 PeptiAID Announces Completion of Last Subject Last Visit in Phase 1 Clinical Trial of COVID-19 Candidate PA-001
2024/10/9 PeptiDream Affiliated Company, PeptiAID Inc., Announces Dosing of First Subject in Phase 1 Clinical Trial of PA-001
2024/7/18 PeptiDream Affiliated Company, PeptiAID Inc., Announces FDA Approval of IND Application for a Phase 1 Clinical Trial of PA-001
2022/8/10 PeptiDream Affiliated Company, PeptiAID Inc., Announces Complete Clinical Research of PA-001, a Candidate Compound for COVID-19 Treatment, Demonstrating Favorable Safety Profile
・Clinical trial information jRCTs031210601
・Presentations
The 70th Annual Meeting of the Japanese Society for Virology
| Number of Patients |
Market Size |
Key Product Sales (Global) |
777 million
(Global, since 2020)(1) |
$7.7bn
(Global, 2024)(2) |
Paxlovid®
$5.7bn (2024)(3) |
- Number of Patients
- 777 million
(Global, since 2020)(1)
- Market Size
- $7.7bn
(Global, 2024)(2)
- Key Product Sales (Global)
- Paxlovid®
$5.7bn (2024)(3)
Notes: (2) Total global sales of Ronapreve®, Veklury®, Paxlovid® and Xocova® in 2024
Source: (1) WHO Coronavirus (COVID-19) Dashboard (as of Jan 2024) (3) Evaluate
Non-exclusive Technology License
- Modality: Therapeutic peptide
- Origin: Merck
Phase1 study of clinical candidate which was identified by MSD using PDPS technology non-exclusively licensed from PeptiDream is started from July 2023.
Discovery Research Collaboration
・Indication: Autoimmune diseases
・Mechanism of action: Selective TNF receptor 1 inhibitor
・Modality: Therapeutic peptide
・Origin: PeptiDream
AK1940 is a macrocyclic peptide discovered through a research collaboration between the two companies using PeptiDream’s proprietary Peptide Discovery Platform System (PDPS).
AK1940 showed potent inhibitory activity and high selectivity for TNFR1 and exhibited efficacy in animal models of inflammatory disease, supporting its potential for the treatment of a broad range of autoimmune diseases.
・Press Releases
2026/4/20 PeptiDream Announces the Initiation of Phase 1 Clinical Trial by Its Collaboration Partner
・Clinical tial information: jRCT2071250141
Strategic Alliance
- Indication: Mast cell-driven allergic diseases
- Mechanism of Action: KIT inhibitor
- Modality: Therapeutic small molecule
- Origin: Alivexis (Desined using hit peptide)
Selective small molecule inhibitor of KIT, a key signaling kinase involved in the Mast cell response pathway, for the potential treatment of Mast-cell driven immuno-inflammatory diseases arising from the companies' strategic drug discovery partnership. Modulus will be responsible for conducting IND-enabling studies with the aim of moving the MOD-B program into clinical trials, as well as leading all partnering/out-licensing activities for the program.
Press Releases
2023/8/3 PeptiDream and Modulus Announce Nomination of First Clinical Development Candidate from Strategic Partnership
