This section highlights FDA-related milestones and regulatory updates for drugs developed by Adagene (ADAG).
Over the past two years, Adagene has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ADG138, muzastotug, ADG126, and ADG126. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ADG138 FDA Regulatory Events
ADG138 is a drug developed by Adagene for the following indication: a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADG138
- Announced Date:
- September 22, 2026
- Indication:
- a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager
Announcement
Adagene Inc. announced that China’s National Medical Products Administration (NMPA) has approved the company’s investigational new drug (IND) application for ADG138, a double-masked HER2×CD3 bispecific T cell engager built on Adagene’s proprietary SAFEbody® precision masking technology.
Read Announcement
Muzastotug FDA Regulatory Events
Muzastotug is a drug developed by Adagene for the following indication: Late-line Patients with Microsatellite Stable Colorectal Cancer Demonstrate Improved Durability of Response.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- muzastotug
- Announced Date:
- April 2, 2026
- Indication:
- Late-line Patients with Microsatellite Stable Colorectal Cancer Demonstrate Improved Durability of Response
Announcement
Adagene Inc announced results from the latest data cut from its Phase 1b/2 study of muzastotug in patients with advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases.
AI Summary
Adagene announced results from the latest data cut of its Phase 1b/2 study testing muzastotug in patients with advanced microsatellite stable colorectal cancer (MSS CRC) who did not have liver metastases. The company said the updated data showed encouraging signs of anti-tumor activity and a manageable safety profile in this specific group of patients. The findings suggest muzastotug may be active where many therapies struggle, particularly in MSS CRC without liver involvement.
Adagene and partners view these results as supportive evidence to advance muzastotug as a backbone for future immuno-oncology combinations. The company plans further development and additional combination studies to build on this data, aiming to better define the drug’s benefits and the patients most likely to respond.Read Announcement
ADG126 FDA Regulatory Timeline and Events
ADG126 is a drug developed by Adagene for the following indication: Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADG126
- Announced Date:
- March 17, 2026
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced that muzastotug will be highlighted in two poster presentations at this year's AACR Meeting, taking place April 17-22 in San Diego, CA.
AI Summary
Adagene Inc. announced that muzastotug will be highlighted in two poster presentations at the American Association for Cancer Research (AACR) annual meeting, scheduled April 17–22 in San Diego. The company said the abstracts for these posters were selected for presentation at AACR 2026, bringing attention to muzastotug’s data and development progress. The announcement emphasizes the role of these presentations in sharing preclinical and clinical findings with the cancer research community.
Adagene also noted that SAFEbody® is a registered trademark in multiple countries, indicating muzastotug is part of its SAFEbody platform. The AACR posters offer an opportunity for researchers and clinicians to review detailed results and ask questions directly to Adagene representatives during the conference. The company positioned the presentations as a step forward in advancing scientific understanding and potential clinical use of muzastotug.
Read Announcement- Drug:
- ADG126
- Announced Date:
- December 16, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck's (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without current or active liver metastases.
AI Summary
Adagene announced that the U.S. Food and Drug Administration has granted Fast Track designation to muzastotug in combination with Merck’s KEYTRUDA® (pembrolizumab) for adults with microsatellite stable metastatic colorectal cancer (MSS mCRC) who do not have current or active liver metastases. The Fast Track status is meant to help speed development and review of treatments for serious conditions with unmet needs.
Muzastotug is a next‑generation masked anti‑CTLA‑4 SAFEbody designed to overcome CTLA‑4–driven regulatory T‑cell resistance in tumors. Its masking technology aims to activate the antibody mainly inside the tumor microenvironment, reducing systemic toxicity while keeping anti‑tumor effects. Early clinical results have shown encouraging responses, durability, and a favorable safety profile in heavily pretreated patients.
Adagene is continuing randomized Phase 2 studies of muzastotug plus pembrolizumab and is preparing for a registration trial, with updated topline Phase 1b/2 data expected in the coming months.
Read Announcement- Drug:
- ADG126
- Announced Date:
- July 15, 2025
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc. announced that Company expects to begin enrolling patients in Phase 2 in 2H 2025
AI Summary
Adagene Inc. announced plans to begin enrolling patients in its Phase 2 trial in the second half of 2025. The trial will evaluate ADG126, a masked anti-CTLA-4 SAFEbody, used in combination with pembrolizumab for the treatment of microsatellite stable colorectal cancer. The study is designed to compare two dosing regimens—10 mg/kg and 20 mg/kg of ADG126—in an induction-maintenance format without limitations on treatment cycles. Approximately 30 patients will be enrolled in each dosing arm. The primary endpoint of the trial will be the overall response rate, while secondary endpoints include progression-free survival, overall survival, and duration of response. This move follows promising dose-dependent efficacy and a favorable safety profile from earlier studies, and it sets the stage for identifying the optimal dose to advance into a Phase 3 registrational trial for potential FDA approval.
Read Announcement- Drug:
- ADG126
- Announced Date:
- July 15, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc. announced outcomes from its Type B meeting with the United States Food and Drug Administration (FDA).
AI Summary
Adagene Inc. announced positive outcomes from its recent Type B meeting with the FDA regarding its clinical development plan for ADG126 in combination with pembrolizumab for patients with microsatellite stable colorectal cancer. The FDA provided written feedback on the proposed Phase 2 trial design, confirming alignment on the inclusion/exclusion criteria, primary and secondary endpoints, and overall study design. In the Phase 2 study, approximately 30 patients per arm will be randomized to receive either 10 mg/kg or 20 mg/kg of ADG126 alongside pembrolizumab on an induction-maintenance schedule. The primary endpoint for this phase will be overall response rate, while secondary endpoints include duration of response, progression-free survival, and overall survival. Additionally, the FDA agreed with the proposed standard-of-care control arm for the Phase 3 trial, further supporting the advancement of the clinical program.
Read Announcement- Drug:
- ADG126
- Announced Date:
- May 22, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases at ASCO.
AI Summary
Adagene Inc. presented updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) without liver metastases at ASCO. The study focused on the 20 mg/kg dosing schedule every six weeks when used in combination with pembrolizumab. Researchers noted that this regimen resulted in fewer than 20% Grade 3 adverse events, with no patient discontinuations due to toxicity. Importantly, the confirmed overall response rate reached 29%, and all responders in the 20 mg/kg cohorts remain on treatment—with several patients continuing for over 40 weeks. These promising results were observed even in patients with peritoneal involvement. The data show both a favorable safety profile and durable responses compared to historical controls. Adagene plans to discuss dosing regimens with regulatory bodies as it continues to develop ADG126, aiming to maximize treatment efficacy while minimizing side effects.
Read Announcement- Drug:
- ADG126
- Announced Date:
- February 27, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc. announced an investigator initiated (IIT) Phase 2 neoadjuvant trial of ADG126 for patients with stage II or stage III colorectal cancer.
AI Summary
Adagene Inc. announced a Phase 2 investigator-initiated neoadjuvant trial to evaluate ADG126 in patients with stage II or stage III colorectal cancer. The trial, scheduled to start enrollment in April 2025, will explore the use of ADG126 in combination with KEYTRUDA® prior to surgery. Led by Dr. Yong Wei Peng from the National University Cancer Institute in Singapore, the study aims to determine the rate of major pathologic response, which is defined as having 10% or less of viable tumor left after treatment. Up to 20 patients will be enrolled, and secondary goals include analyzing complete pathological response, disease-free survival, safety, and how the drugs affect the tumor’s immune environment.
Read Announcement- Drug:
- ADG126
- Announced Date:
- January 27, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA.
AI Summary
Adagene Inc recently shared promising clinical results for its cancer therapy ADG126 at the ASCO Gastrointestinal Cancers Symposium in San Francisco, CA. In a Phase 1b/2 trial for patients with microsatellite stable colorectal cancer, the study evaluated a 20 mg/kg loading dose of ADG126 followed by 10 mg/kg every three weeks, given together with the immunotherapy drug pembrolizumab. The updated data showed that 33% of the patients responded to treatment, with four out of twelve patients experiencing confirmed partial tumor shrinkage. Importantly, no severe treatment-related side effects were reported, and no patients had to stop treatment because of adverse events. These findings suggest that ADG126 has the potential to be a safe and effective option for patients battling this form of colorectal cancer, supporting further investigation in larger studies.
Read Announcement- Drug:
- ADG126
- Announced Date:
- October 9, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced poster presentations at the upcoming SITC 39th Annual Meeting, taking place in Houston, Nov. 6 – 10, 2024.
AI Summary
Adagene Inc has announced that it will present two posters at the upcoming SITC 39th Annual Meeting in Houston, scheduled from November 6 to 10, 2024. The company will share data on its clinical studies involving the masked anti-CTLA-4 SAFEbody, muzastotug (ADG126). One poster presentation will focus on how muzastotug shows an improved clinical therapeutic index compared to its unmasked form, ADG116, when used alone or alongside anti-PD-1 therapy. A separate presentation will detail findings from a Phase 1b/2 clinical study evaluating the combination of ADG126 with pembrolizumab in advanced or metastatic MSS colorectal cancers. Both sessions are set for November 9, featuring a lunchtime viewing followed by an evening poster reception, all held at the George R. Brown Convention Center. Additional details and the posters will be available on the company’s website.
Read Announcement
ADG126 + KEYTRUDA (pembrolizumab) FDA Regulatory Events
ADG126 + KEYTRUDA (pembrolizumab) is a drug developed by Adagene for the following indication: Advanced/metastatic solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADG126 + KEYTRUDA (pembrolizumab)
- Announced Date:
- January 21, 2025
- Indication:
- Advanced/metastatic solid tumors
Announcement
Adagene Inc announced it will share updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA on Saturday, January 25, 2025.
AI Summary
Adagene Inc. announced it will share updated clinical data from its ongoing Phase 1b/2 study of ADG126, an anti-CTLA-4 SAFEbody, in patients with microsatellite stable colorectal cancer (MSS CRC). The study, conducted in combination with Merck’s KEYTRUDA® (pembrolizumab), previously showed efficacy with a 10 mg/kg dose every three weeks. The new data will include initial results using a 20 mg/kg loading dose followed by 10 mg/kg every three weeks, aiming to further evaluate the treatment’s potential in this hard-to-treat cancer type.
This presentation is scheduled for the ASCO Gastrointestinal Cancers Symposium in San Francisco, CA, on Saturday, January 25, 2025. Attendees will gain insights into the evolving treatment landscape for advanced/metastatic MSS CRC and the role of CTLA-4 targeting in overcoming challenges associated with these "cold" tumors.
Read Announcement- Drug:
- ADG126 + KEYTRUDA (pembrolizumab)
- Announced Date:
- January 14, 2025
- Target Action Date:
- January 25, 2025
- Indication:
- Advanced/metastatic solid tumors
Announcement
Adagene Inc announced it will host a virtual key opinion leader (KOL) event on Saturday, January 25, 2025 at 1:00 PM ET, featuring Aurélien Marabelle, MD, PhD (Université Paris-Saclay), Daneng Li, MD (City of Hope), and Marwan Fakih, MD (City of Hope), who will join company management to discuss the unmet need and current treatment landscape for patients with advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) and why CTLA-4 targeting is essential for achieving durable responses in this cold tumor type.
AI Summary
Adagene Inc. announced a virtual key opinion leader (KOL) event scheduled for Saturday, January 25, 2025 at 1:00 PM ET. The event will feature top experts including Dr. Aurélien Marabelle from Université Paris-Saclay, and Dr. Daneng Li and Dr. Marwan Fakih from City of Hope. They will join Adagene’s management team to focus on the current treatment challenges and unmet needs for patients with advanced or metastatic microsatellite-stable (MSS) colorectal cancer. The panel will discuss why targeting CTLA-4 is critical for achieving long-lasting responses in this challenging “cold” tumor type. By addressing the limitations of existing therapies, the discussion aims to shed light on innovative strategies that could improve patient outcomes in MSS colorectal cancer, a disease that has historically been resistant to many current treatment options.
Read Announcement
