CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Advanced Gastroesophageal Junction AdenocarcinomaCLDN18.2 positive Gastroesophageal junction adenocarcinomaCLDN18.2 positive stomach adenocarcinoma+ [13]

Inactive Indication

AdenocarcinomaAdenocarcinoma of EsophagusCLDN18.2 Positive Gastrointestinal Neoplasms+ [1]

Originator Organization

Ganymed Pharmaceuticals AG

Active Organization

Astellas Pharma Global Development, Inc.Astellas Pharma Europe BV

Astellas Pharma China, Inc.

+ [5]

Inactive Organization

Ganymed Pharmaceuticals AG

License Organization

Shanghai Pharmaceutical Co., Ltd.

Ganymed Pharmaceuticals AG

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (26 Mar 2024),

CLDN18.2 positive Stomach Cancer

RegulationAccelerated Approval (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States)

Structure/Sequence

Sequence Code 431594752L

Source: *****

Sequence Code 524309292H

Source: *****

Clinical Trials associated with Zolbetuximab

JPRN-UMIN000060223

/ RecruitingNot ApplicableIIT

Investigation of gastric cancer treatment using zolbetuximab - Zolbetuximab Gastric Analysis 1

Start Date09 Dec 2025

Sponsor / Collaborator-

NCT06396091

/ Active, not recruitingPhase 1

A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.
In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.
Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.
There are 2 main aims of this study:
* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer
* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.
Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.
People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.
People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.

Start Date24 Sep 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06901531

/ RecruitingPhase 3

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Start Date22 May 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

100 Clinical Results associated with Zolbetuximab

100 Translational Medicine associated with Zolbetuximab

100 Patents (Medical) associated with Zolbetuximab

144

Literatures (Medical) associated with Zolbetuximab

01 Apr 2026·DEN open

Endoscopic Complete Response to Zolbetuximab for Advanced Gastric Cancer With Claudin 18.2 Positive: A Case Report

Article

Author: Yoshioka, Tsubasa ; Kimura, Rika ; Yamaba, Tomohiro ; Uchiyama, Gaku ; Sasaki, Akinori ; Tachibana, Ayu ; Okamoto, Risa

ABSTRACT:

Recently, zolbetuximab combined with chemotherapy has been approved as a first‐line treatment for advanced gastric cancer (GC). However, to date, no endoscopic images demonstrating endoscopic complete response (eCR) to zolbetuximab plus chemotherapy have been reported. Herein, we report the case of an 80‐year‐old man who presented with epigastric pain and loss of appetite and was diagnosed with undifferentiated GC and peritoneal metastasis. The patient received modified FOLFOX6 plus zolbetuximab because genetic testing revealed HER2‐negative and claudin 18.2‐positive. He experienced grade 2 nausea, which improved with the administration of antiemetic agents. Computed tomography performed at month 5 showed resolution of peritoneal dissemination. Endoscopic examination during the same period showed the disappearance of the primary gastric tumor with scarring. Biopsy of the scar area revealed only inflammatory cells; therefore, the primary lesion was defined as an eCR. To the best of our knowledge, this is the first report of eCR to zolbetuximab and chemotherapy in a patient with GC and claudin 18.2 positive. This case report suggested that chemotherapy combined with zolbetuximab may offer greater therapeutic benefit than chemotherapy combined with immune checkpoint inhibitors in patients with undifferentiated GC. Further analysis is expected to enable the identification of patients with claudin 18.2‐positive GC in whom zolbetuximab treatment is effective.

01 Jan 2026·JOURNAL OF NUCLEAR MEDICINE

Claudin 18.2 as a Biomarker for Imaging and Radiopharmaceutical Therapy in Gastric and Pancreatic Tumors

Article

Author: Mahmood, Umar ; Strickland, Matthew R ; Haj-Mirzaian, Arvin ; Ting, David T ; Klempner, Samuel J ; Khazaei Monfared, Yousef ; Larimer, Benjamin M ; Raheem, Shvan J ; Heidari, Pedram ; Esfahani, Shadi A ; Bashyal, Santosh

Claudin 18.2 (CLDN18.2) is a tight-junction protein overexpressed and differently exposed in solid tumors such as gastric cancer (GCa), gastroesophageal junction adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC). We sought to explore the potential of CLDN18.2 as a biomarker for molecular imaging and targeted radiopharmaceutical therapy in GCa and PDAC models. Methods: Bulk and single-cell RNA sequencing for CLDN18.2 from 31 patients with PDAC were performed. Subcutaneous xenografts of GCa with the GSU cell line and PDAC with HUPT-4 and PATU8988S cell lines were developed in nude mice. Serial PET imaging with ⁸⁹Zr-labeled zolbetuximab, an anti-CLDN18.2 monoclonal antibody ([⁸⁹Zr]Zr-DFO-zolbetuximab), and human IgG ([⁸⁹Zr]Zr-DFO-IgG) as control (5.5-7.4 MBq) was performed 1, 3, and 6 d after injection, followed by ex vivo analysis of biodistribution. Tumor-bearing mice received a single intravenous injection of [¹⁷⁷Lu]Lu-DOTA-zolbetuximab (7.4 or 14.8 MBq), nonradiolabeled zolbetuximab, [¹⁷⁷Lu]Lu-DOTA-IgG, [¹⁷⁷Lu]Lu-DOTA, or saline as the control. Toxicity of [¹⁷⁷Lu]Lu-DOTA-zolbetuximab was evaluated by laboratory and histologic analyses over 90 d. Results: RNA sequencing confirmed significantly higher expression of CLDN18.2 in human PDAC compared with noncancerous pancreas tissue, with no significant difference between treated and untreated tumors. Serial PET imaging demonstrated a high tumor uptake of [⁸⁹Zr]Zr-DFO-zolbetuximab at all 3 time points (mean uptake on day 6: 24.4 ± 7.8 %ID/g in GSU; 36.6 ± 10.1 %ID/g in PATU8988S; 16.48 ± 4.7 %ID/g in HUPT-4), and significantly higher than the uptake seen in mice imaged with [⁸⁹Zr]Zr-DFO-IgG (day 6: 4.8 ± 1.9 %ID/g in GSU; P = 0.0029). The highest tumor-to-background uptake ratio was achieved on day 6 (GSU tumor-to-muscle ratio, 14.85 ± 7.8). Biodistribution analyses were consistent with the PET imaging results. High-dose [¹⁷⁷Lu]Lu-DOTA-zolbetuximab (14.8 MBq) resulted in reduced tumor growth in GSU and PATU8988S over 4 and 8 wk, respectively, with complete regression of most HUPT-4 tumors and improved 90-d survival compared with the mice treated with control conditions. The 90-day treatment toxicity assay indicated a favorable safety profile. Conclusion: CLDN18.2 could serve as a promising biomarker for precise quantitative imaging and effective treatment of GCa and PDAC. This proof-of-concept study encourages the clinical translation of CLDN18.2 as a radiotheranostic in patients with CLDN18.2-expressing tumors.

01 Jan 2026·Journal of Gastric Cancer

CLDN18.2 in Gastric Cancer: Current Therapeutic Landscape and Future Perspectives

Review

Author: Zhang, Fei ; Okazaki, Ukyo ; Shitara, Kohei ; Nakayama, Izuma

Claudin 18.2 (CLDN18.2), a tight junction protein selectively expressed in normal gastric epithelium and widely retained during carcinogenesis, has emerged as a promising therapeutic target for advanced gastric cancer (AGC). SPOTLIGHT and GLOW trials evaluated the anti-CLDN18.2 monoclonal antibody (mAb) zolbetuximab in combination with first-line chemotherapy, and established CLDN18.2 as a therapeutic target, initiating a paradigm shift toward a biomarker-driven treatment approach in AGC. In addition, from zolbetuximab to a diverse pipeline of promising high-affinity mAbs, bispecific antibodies, antibody-drug conjugates and chimeric antigen receptor T cells, this target has established a new and highly effective therapeutic avenue for CLDN18.2-expressing AGC. Therefore, as research progresses, CLDN18.2-targeted therapy is poised to become a cornerstone of treatment across multiple disease stages and cancer types. This review describes the biological role of CLDN18.2 in normal gastric epithelium and gastric carcinogenesis and summarizes the current therapeutic landscape and future perspectives targeting CLDN18.2 in AGC.

122

News (Medical) associated with Zolbetuximab

24 Feb 2026

·www.biospace.com

Astellas Bets up to $1.7B for Vir’s ‘Robust Competitor’ in Prostate Cancer

iStock, master1305 In a Phase 1 study, 82% of patients on VIR-5500 achieved at least a 50% reduction in PSA levels—a result analysts praised as competitive in the prostate cancer space. Astellas Pharma is committing $335 million and betting over a billion more to collaborate with Vir Biotechnology on a T cell engager that analysts at Truist Securities called a “robust competitor” in the prostate cancer market. Under the terms of the agreement, Astellas will make a $240 million cash payment, a $75 million equity investment and pay a $20 million near-term award. Vir will also be eligible for up to $1.37 billion in development, regulatory and sales milestones, plus double-digit royalties on sales outside the U.S., according to a Monday release . The deal’s centerpiece is VIR-5500, an investigational T cell engager that uses a bispecific molecule to bind to both the prostate-specific membrane antigen (PSMA) and CD3 proteins. Through this mechanism of action, the drug stimulates the immune system and directs its response to the target malignant cells. VIR-5500 was developed using Vir’s PRO-XTEN masking technology , which renders therapies inactive until they are in the vicinity of a tumor. Phase 1 data, also released Monday , showed that VIR-5500 elicited a dose-dependent anti-tumor response, with 82% of treated patients achieving a 50% or greater decrease in prostate-specific antigen (PSA) levels, a biomarker of the cancer. Meanwhile, 53% saw at least a 90% PSA reduction. Reacting to the early-stage readout, Truist said VIR-5500 “emerges as a more robust contender” among PSMA-targeting therapies. Vir’s masking technology, they continued, “enables high-dose VIR-5500 administration,” leading to stronger treatment responses than other treatments under development. Under the terms of the agreement, Astellas will be responsible for 60% of VIR-5500’s global development costs, while Vir will shoulder the remaining 40%. Vir will continue to conduct the asset’s Phase 1 development, after which Astellas will take over all subsequent development activities. Vir will have the option to co-promote VIR-5500 in the U.S., with profits and losses split evenly. Astellas will have exclusive rights abroad. The deal for VIR-5500 beefs up Astellas’ prostate cancer portfolio, which currently is anchored by the oral drug Xtandi . In the first nine months of the company’s 2025 fiscal year, Xtandi made $4.72 billion . The biotech is also advancing abiraterone decanoate, a small-molecule drug in Phase 2 development. Astellas’ other cancer products include the Pfizer-partnered bladder cancer drug Padcev and the stomach cancer therapy Vyloy. For Vir, the Astellas agreement gives it access not just to additional capital but also to a proven market infrastructure. “Astellas’ established commercial footprint in prostate cancer through Xtandi further strengthens the strategic positioning of VIR-5500,” Truist said.

Phase 1License out/inPhase 2Clinical ResultPROTACs

06 Feb 2026

·www.fiercepharma.com

Fierce Pharma Asia—Amgen, Kyowa's OX40 divorce; Roche's RNAi deal; Daiichi's ADC cull

Another blow to the OX40 class, Roche's latest RNAi deal, and the discontinuation of a next-gen ADC at Daiichi Sankyo make our news this week. Amgen added to uncertainty surrounding the OX40 drug class by returning an autoimmune candidate to Kyowa Kirin. Roche penned a deal worth up to $1.7 billion for an RNA interference program from SanegeneBio. Daiichi Sankyo stopped development of its first non-DXd candidate. And more.1. Amgen jilts Kyowa, exiting $400M autoimmune pact after running vast pivotal programThe prospect of the OX40 class for autoimmune disease is suddenly looking bleak. After Sanofi reported mixed phase 3 atopic dermatitis data on amlitelimab, including a case of Kaposi’s sarcoma, Amgen has terminated its rocatinlimab collaboration with Kyowa Kirin. While Kyowa attributed the decision to portfolio reasons at Amgen, the Japanese pharma later disclosed a case of Kaposi’s sarcoma as well.2. Roche's return to RNA continues with $1.7B deal for Sanegene programRoche is paying $200 million upfront for an RNA interference program from Sino-American biotech SanegeneBio. The target and disease area were not disclosed. Sanegene could be in line for up to $1.5 billion in development and sales milestones. The deal came as Roche and another RNAi partner, Alnylam Pharmaceuticals, moved their hypertension candidate zilebesiran into phase 3 testing.3. Daiichi stops internal development of next-wave ADC as key Datroway readout delayed againDaiichi Sankyo has discontinued internal development of DS-9606, the first candidate based on the company’s second antibody-drug conjugate platform using a modified pyrrolobenzodiazepine (mPBD) payload. Daiichi suggested the CLDN6-directed candidate has shown some good early data in the germ cell tumor setting that has “confirmed the utility” of the mPBD platform.4. India will invest $1.1B to boost development of biologics, biosimilarsIndia is launching the Biopharma Strategy for Healthcare Advancement through Knowledge, Technology and Innovation (SHAKTI) initiative, which is designed to support the domestic development of biologics. The country will invest 100 billion rupees ($1.1 billion) over the next five years to increase research and production of biologic drugs.5. Chugai drops only AI-assisted antibody from pipeline but still holds high hopes for techRoche’s Chugai has nixed its only clinical candidate that was discovered with the help of an in-house artificial intelligence tool called Malexa. The phase 1 chronic disease antibody BRY10 was dropped from the pipeline “based on a comprehensive review” of data, a Chugai spokesperson said. The spokesperson said the discontinuation was unrelated to Malexa itself.6. Astellas tops expectations as Vyloy sales surge outshines trial setbackAstellas’ quarterly sales beat analysts’ consensus by 8% thanks to strong performance from cancer drugs Padcev and Vyloy. As the first FDA-approved CLDN18.2 agent, Vyloy saw sales quadruple to about $125 million in the last three months of 2025, even as the drug hit a midstage setback in pancreatic cancer. Astellas also discontinued a KRAS G12D protein degrader in favor of another.Other News of Note: 7. Roche diagnostics business nudges up 2% in '25 as China headwinds buffet Asia-Pacific sales8. FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program9. AZ, Daiichi nab priority review tag as Datroway homes in on next FDA nod (regulatory tracker)10. Sun Pharma marks Super Bowl ‘SUNday’ with skin cancer awareness drive11. China's Newsoara pens $135M deal for remaining rights to vTv's inflammation drug12. Eisai nabs rights to sell Henlius’ PD-1 in Japan for $75M upfront (release)

Phase 3Drug ApprovalPriority ReviewADCPhase 1

05 Feb 2026

·www.fiercebiotech.com

Astellas tops expectations as Vyloy sales surge outshines trial setback

Astellas raised its full-year fiscal 2025 revenue forecast by 10% to 2.1 trillion yen, thanks to the strong performance of Padcev and Vyloy.\n Astellas surpassed market expectations in its third-quarter fiscal year 2025 results, as first-in-class cancer drug Vyloy defied a trial setback to deliver quadrupled sales.As the first CLDN18.2 agent to reach the market, Vyloy saw sales swell (PDF) 426% to 19.5 billion Japanese yen ($125 million) during the last three months of calendar year 2025, which marked Astellas’ Q3.In a Wednesday note, Jefferies analysts said they were “impressed by the rapid rise in demand” for the stomach cancer treatment.The strong performance from Vyloy helped Astellas beat analysts’ expectations for total third-quarter sales by 8%, according to Jefferies.Vyloy’s commercial surge comes after Astellas reported a midstage trial failure for the antibody in pancreatic cancer in October. At that time, Astellas said the impact of the trial setback on its financial results for the year was expected to be minor.Moving into the earnings report, Astellas booked a loss of 12.8 billion yen ($82 million) in Q3, tied to the discontinuation of the pancreatic cancer program. Also in pancreatic cancer, Astellas terminated ASP4396, a phase 1 KRAS G12D program, to focus on setidegrasib (ASP3082), another KRAS G12D protein degrader. The difference between the two drugs lies in their E3 ligase design. The prioritization decision was made because ASP4396’s data have yet to top its counterpart’s, despite being later in development, Astellas’ R&D chief Tadaaki Taniguchi said on a Feb. 4 earnings call.A combination of setidegrasib and chemo recently posted a 58.3% objective response rate among 12 patients in first-line pancreatic cancer. Based on the results, Astellas plans to launch a phase 3 study in the indication by March, and it’s also planning registrational studies in non-small cell lung cancer.Astellas would like to accelerate the development of setidegrasib in pancreatic cancer, Taniguchi said, noting that its competitor, Revolution Medicines, has not started a first-line pivotal study.Last year’s clinical setback apparently didn’t dampen enthusiasm around the use of Vyloy in the closing months of 2025. During an investor call Wednesday, Astellas CFO Atsushi Kitamura attributed the drug’s commercial progress to “high Claudin 18 testing rates and lower-than-expected discontinuation rates.”“By focusing on the prevention of nausea and vomiting, particularly in the initial cycle, we believe we can reduce discontinuation and enhance treatment continuation rate,” he said, according to a call transcript provided by Astellas.Astellas is now testing Vyloy in combination with Merck & Co.’s Keytruda and chemotherapy in the phase 3 Lucerna trial in first-line stomach cancer. Enrolled patients have CLDN18.2-high, PD-L1-positive tumors. The company expects an interim readout in its fiscal year 2027 or later.Besides Vyloy, Pfizer-partnered Padcev contributed about a third of Astellas’ overall Q3 sales growth. Sales of the star antibody-drug conjugate jumped 45% during the quarter, reaching 60.1 billion yen ($383 million).In November, the FDA handed down a groundbreaking approval for a combination of Padcev and Keytruda as the first perioperative treatment for patients with muscle-invasive bladder cancer (MIBC) who can’t receive cisplatin-based chemotherapy. The indication was approved just a month after the FDA accepted Astellas and Pfizer’s application.On a winning streak, the Padcev-Keytruda perioperative regimen was also said to have extended the lives of MIBC patients who are cisplatin-eligible in the phase 3 Keynote-B15 (EV-304) trial.Doctors have already started using Padcev in perioperative MIBC, Claus Zieler, Astellas’ chief commercial and medical affairs officer, said during the Feb. 4 investor call. But he cautioned that, based on Astellas’ experience with past Padcev indications, there will be “a very sharp plateau” after “a very fast uptake” in the first six months of rollout as the company tries to penetrate the new patient population completely. Thanks to the strong performance of Padcev and Vyloy, Astellas raised its full-year fiscal 2025 revenue forecast by 10% to 2.1 trillion yen. The company collected 1.6 trillion in the nine months that ended in December.Padcev and Vyloy are two of Astellas’ five strategic brands, which together are nearing 500 billion yen sales on a full-year basis, Kitamura said.Astellas is pinning its future on the strategic brands—which also include menopause therapy Veozah, eye med Izervay and leukemia drug Xospata—as its Pfizer-partnered prostate cancer juggernaut Xtandi nears a 2027 U.S. patent cliff. In Q3, Veozah and Izervay expanded sales by 28% and 33%, respectively, while Xospata was relatively flat.In the pipeline, Astellas has highlighted four “primary focus flagship programs.” Besides setidegrasib, the group also includes ASP2138, a CLDN18.2xCD3 bispecific; AT845, a gene therapy designed for Pompe disease; and ASP7317, a cell therapy for geographic atrophy.In Q3, Astellas reports that it achieved proof of concept for ASP2138 in first-line stomach cancer and is now preparing to launch a phase 3 trial.“This is very good news because it means that Astellas now has a healthy-looking late-stage R&D pipeline,” the Jefferies analysts said. “This, matched with its fast-growing portfolio of on-market products, is likely to broaden the appeal of Astellas\' stock to a broader group of investors.”

Phase 1Phase 3Drug ApprovalClinical ResultADC

100 Deals associated with Zolbetuximab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Zolbetuximab	-	DB15118

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Canada	Astellas Pharma Canada, Inc.	09 Jan 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive stomach adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive Stomach Cancer	Japan	Astellas Pharma, Inc.	26 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic gastric adenocarcinoma	Phase 3	United States	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	China	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	Japan	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	Australia	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	Belgium	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	Brazil	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	Canada	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	Chile	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	Czechia	Astellas Pharma Global Development, Inc.	31 Jul 2025
Metastatic gastric adenocarcinoma	Phase 3	France	Astellas Pharma Global Development, Inc.	31 Jul 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06901531 (LUCERNA, ASCO_GI2026)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| PD-L1 positive Solid Tumors \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2-positive \| HER2-negative \| PD-L1-positive	500	Zolbetuximab + pembrolizumab + CAPOX/mFOLFOX6	snujallaus(ktoegjkjfi) = scyixrrqwl uuiuvyosyg (ofhxhbovcb, 24.9 - NR)	Positive	08 Jan 2026
				Placebo + pembrolizumab + CAPOX/mFOLFOX6	dnroderqho(psqwpfgmag) = ynwrexapoz uhqesiuatc (khuzpmpirx, 43.1 - 56.9) View more
ESMO_ASIA2025	Not Applicable	Advanced gastric carcinoma	17	Zolbetuximab+antiemetic therapy+atypical antipsychotics	fceerpxdjw(qjvnotzqus) = vfywkwysja uaygceprym (zicdxzudjx ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Advanced Gastroesophageal Junction Adenocarcinoma First line	22	Zolbetuximab (Zolb) + chemo	jqnfxqubhr(hvpzrhuukd) = abdominal pain (18%) lnvvddbtxp (iguwvjakjz ) View more	Positive	05 Dec 2025
NCT03504397 (SPOTLIGHT, ESMO_ASIA2025)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2+ \| HER2−	374	Zolbetuximab plus mFOLFOX6/CAPOX	dsbzjdzsgc(rrdkjnjrfe) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). ivoxydaexl (aqbsvzskrt ) View more	Positive	05 Dec 2025
				Placebo plus mFOLFOX6/CAPOX
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	Phase 3	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	gbjgkbfogk(eiwygkebmk) = lhqvfazigu rndlcwkwgi (mhcjjtycui, sorldtszov - dvrblsvzvh) View more	-	26 Feb 2025
NCT03653507 (GLOW, CTgov)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	pippaxletj(klrcbqspol) = ceunoxvgbw fdrokhlsjp (xtduifzuwe, bfzfynupid - wxmxqzkbdj) View more	-	27 Jan 2025
				Placebo (CAPOX+ Placebo)	pippaxletj(klrcbqspol) = tmoczqgfwp fdrokhlsjp (xtduifzuwe, foaotcnikj - zmincatjnl) View more
NCT03504397 (SPOTLIGHT, NEWS) Manual	Phase 3	Gastroesophageal junction adenocarcinoma First line CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	xipbnjjxia(ypbshtydnp) = pekolxvltc btudkcdsan (hcutokbxkg, 6.7 - 16.7) View more	Positive	28 Sep 2024
				安慰剂+mFOLFOX6	xipbnjjxia(ypbshtydnp) = gwgqwznqzl btudkcdsan (hcutokbxkg, 6.0 - 8.4) View more
NCT03653507 (GLOW, NEWS) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	rnksmirimv(tqvugkujfp) = axkrmqegdj cijpqblesw (zqlvppuagn, 6.1 - 9.1) View more	Positive	28 Sep 2024
				安慰剂联合CAPOX	rnksmirimv(tqvugkujfp) = wvowdtpoyg cijpqblesw (zqlvppuagn, 5.0 - 8.0) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma First line CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	bxaodkmszk(mhvgingoez) = gjmekvqpvs fynrttpzuw (jvdrnmrgok, 8.4 - 10.4) View more	Positive	16 Sep 2024
				Placebo + chemotherapy	bxaodkmszk(mhvgingoez) = zooccamywg fynrttpzuw (jvdrnmrgok, 7.6 - 8.4) View more
NCT03504397 (SPOTLIGHT, ASCO2024) Manual	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	qtoswrzmjr(aibwpappmq) = uhqucgjsva zxbcwefzma (dofrxdfbbi ) View more	Positive	24 May 2024
				Placebo + mFOLFOX6	qtoswrzmjr(aibwpappmq) = puwaespcwo zxbcwefzma (dofrxdfbbi ) View more

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