Breaking News! 9 Promising New Drugs to Watch in 2025

Cancer Treatment

Drug Name: Dato-DXd (Datopotamab deruxtecan)

Company: AstraZeneca/Daiichi Sankyo

Indications: Non-small cell lung cancer (NSCLC), triple-negative breast cancer

Datopotamab deruxtecan is an ADC drug composed of a humanized monoclonal antibody targeting TROP2 and an innovative DNA topoisomerase I inhibitor (DXd).

In December 2024, Dato-DXd received its first global approval in Japan for treating adult patients with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after chemotherapy. In January 2025, the U.S. FDA approved the drug for the same patient group.

In December 2024, the FDA granted Dato-DXd Breakthrough Therapy Designation (BTD) for treating adult NSCLC patients with EGFR mutations (EGFRm) who have progressed after EGFR tyrosine kinase inhibitors (TKI) and platinum-based chemotherapy.

In February 2025, the FDA granted Dato-DXd Priority Review status for the same patient group. Phase III clinical trial (TROPION-Lung01) results are expected in 2025, with FDA review completion anticipated in Q3 2025. This drug could become the first approved TROP2 ADC therapy.

Drug Name: CAR-T Therapy CTX112

Company: CRISPR Therapeutics

Indications: B-cell lymphoma, autoimmune diseases (e.g., lupus)

CTX112 combines CRISPR gene editing with dual-target CAR design, enhancing T-cell activity. Early clinical data showed an objective response rate (ORR) of 67% and a complete response rate (CR) of 42% in 12 patients with diffuse large B-cell lymphoma (DLBCL), with no severe cytokine release syndrome (CRS).

In 2024, the drug's indications expanded to autoimmune diseases. The first systemic lupus erythematosus (SLE) patient was dosed, with initial safety assessments showing promising results. Breakthrough clinical data for autoimmune diseases are expected in 2025. If successful, CTX112 could become the first CRISPR-CAR-T therapy approved for autoimmune diseases, revolutionizing traditional immunosuppressive treatments.

Neurodegenerative Diseases

Drug Name: Bemdaneprocel (DA01)

Company: BlueRock Therapeutics (a Bayer subsidiary)

Indication: Parkinson’s disease

Bemdaneprocel consists of dopamine-producing neurons derived from pluripotent stem cells, implanted into the brains of Parkinson’s patients through surgery. These transplanted cells may rebuild neural networks damaged by Parkinson’s disease, potentially restoring both motor and non-motor functions.

Phase I clinical data showed the study met its primary objectives, demonstrating safety and tolerability in all 12 participants (low and high-dose groups) with no serious adverse events within one year. Phase II trial results are expected in 2025. If positive, this could be the first therapy to repair brain cells in Parkinson’s patients.

Drug Name: Lecanemab (Leqembi)

Company: Eisai/Biogen

Indication: Alzheimer’s disease

LEQEMBI has a dual mechanism of action, continuously clearing protofibrils and rapidly eliminating plaques to combat Alzheimer’s disease. Approved in July 2023 for biweekly intravenous administration, Phase III Clarity AD study data showed that subcutaneous lecanemab increased amyloid plaque clearance by 14% after six months compared to biweekly intravenous administration.

In January 2025, the FDA accepted a Biologics License Application (BLA) for a subcutaneous auto-injector for weekly maintenance dosing. If approved, this would be the first at-home auto-injector treatment for Alzheimer’s, reducing the need for hospital visits and improving patient convenience. The drug is also being considered for early-stage Alzheimer’s treatment.

Metabolic Diseases

Drug Name: CagriSema

Company: Novo Nordisk

Indications: Obesity, type 2 diabetes

CagriSema is Novo Nordisk’s latest weight-loss drug. Clinical trial data showed an average weight reduction of 22.7% over 68 weeks, with 40.4% of patients losing more than 25% of their body weight. However, despite promising results, the data did not meet market and investor expectations, leading to a stock decline.

Side effects such as nausea and constipation impacted patient adherence, raising concerns among investors. In response, Novo Nordisk launched the REDEFINE11 trial to optimize dosage and treatment duration. The REDEFINE series results in the coming months will be critical for the drug’s future.

Infectious Diseases

Drug Name: mRNA-1083

Company: Moderna

Indication: Combined flu & COVID-19 vaccine

The world's first mRNA-based flu/COVID-19 bivalent vaccine. Phase III trials are expected to conclude in 2025, potentially advancing vaccine technology.

Drug Name: VIR-3434

Company: Vir Biotechnology

Indication: Chronic hepatitis B

A monoclonal antibody blocking virus entry into liver cells and clearing surface antigens. Phase II trials showed functional cure potential, with critical clinical development expected in 2025.

Cardiovascular Diseases

Drug Name: Milvexian

Company: Bristol-Myers Squibb (BMS)/Janssen

Indication: Stroke prevention

An oral factor XIa inhibitor that reduces thrombosis while lowering bleeding risks. Phase II trials showed superior safety compared to traditional anticoagulants like warfarin and DOACs. The ongoing Phase III LIBREXIA program includes stroke secondary prevention (LIBREXIA-STROKE) and atrial fibrillation (LIBREXIA-AF). Results are expected in 2025, with potential approval in 2026-2027, marking a breakthrough in anticoagulant therapy.

Digital Therapeutics & AI-Driven Drug Development

Drug Name: ISM001-055

Company: Insilico Medicine

Indication: Idiopathic pulmonary fibrosis (IPF)

ISM001-055 targets the rare and fatal disease IPF, characterized by fibroblast proliferation and excessive extracellular matrix deposition, leading to lung function decline and a median survival of 2-3 years.

As the world’s first AI-discovered and designed drug, ISM001-055 successfully completed Phase I studies, demonstrating safety, tolerability, and pharmacokinetic properties. Phase II results are expected in 2025, potentially making it the first AI-developed drug.

Conclusion

New drug development in 2025 will focus on precision targeting (e.g., TROP2, Tau protein), technological breakthroughs (CRISPR, AI-driven design), and early intervention (vaccines, early-stage Alzheimer’s). These innovations may reshape treatment standards, offering new hope for hard-to-treat diseases in cancer, neurodegenerative, and metabolic disorders.