Top Investigational Drugs Nearing Commercialization in 2025

The pharmaceutical landscape continually evolves, marked by groundbreaking research and high-stakes clinical evaluations. Phase 3 trials, often regarded as the final crucial stages for new therapies, play a pivotal role in shaping future therapeutic standards. These trials not only confirm efficacy and safety but also reinforce the scientific commitment to transforming patient care across diverse medical domains. In 2025, several investigational drugs are in the spotlight, that have reached the advanced stages of clinical testing, offering significant insight into potential treatments for complex and chronic diseases. Below are some of the most compelling late-stage drug candidates that stood out for their potential to redefine treatment paradigms.

In-Depth Look at 2025’s Most Promising Drug Candidates

1.    Teva Advances Schizophrenia Care with Promising Phase 3 Long-Acting Injectables

Teva Pharmaceuticals achieved significant milestones in treating schizophrenia with two advanced long-acting injectables. TEV-‘749, an extended-release olanzapine formulation, progressed through the SOLARIS Phase 3 trial, boasting a 92% patient satisfaction rate for its once-monthly, subcutaneous administration. The SteadyTeq platform improves adherence and mitigates risks such as post-injection delirium.

Meanwhile, UZEDY (risperidone), already approved in 2023, continued to show clinical robustness in Phase 3 RISE trials. It maintained efficacy across various demographic profiles and disease severities, underscoring Teva’s leadership in real-world mental health innovation.

2.    IBI354 Enters Phase 3: A Beacon of Hope for Platinum-Resistant Ovarian Cancer

Innovent Biologics initiated the HeriCare-Ovarian01 Phase 3 trial for IBI354, an anti-HER2 antibody-drug conjugate aimed at treating platinum-resistant ovarian cancer. Earlier clinical phases yielded a compelling 40.2% objective response rate and 81.6% disease control rate. This drug combines a monoclonal antibody with a camptothecin payload, offering strong antitumor activity with a manageable safety profile, even for patients with low HER2 expression, a group with historically limited treatment options.

3.    Merck's DOR/ISL Regimen Shows Promise in HIV Phase 3 Trials

Merck presented favorable Phase 3 data on its oral, once-daily combination of doravirine and islatravir for treating virologically suppressed HIV-1 patients. The drug showed non-inferiority compared to existing regimens while maintaining viral suppression over 48 weeks. Islatravir’s novel action as a nucleoside reverse transcriptase translocation inhibitor highlighted Merck's innovation in delivering simplified HIV treatments with durable results.

4.    Vepdegestrant: A Promising Leap in Metastatic Breast Cancer Treatment

Arvinas and Pfizer reported significant Phase 3 outcomes from the VERITAC-2 trial for vepdegestrant, a first-in-class PROTAC estrogen receptor degrader for ER+/HER2- metastatic breast cancer. The oral agent demonstrated superior progression-free survival, especially in patients with ESR1 mutations, a population typically resistant to traditional endocrine therapies. With FDA fast-track status, vepdegestrant may soon transform the therapeutic landscape for advanced breast cancer.

5.    Felzartamab Enters Phase 3 for Tackling Late AMR in Kidney Transplants

Biogen’s Felzartamab entered Phase 3 development under the TRANSCEND trial, aiming to address late antibody-mediated rejection (AMR) in kidney transplant recipients. Targeting CD38 to deplete pathogenic plasma cells, the trial enrolled 120 participants globally. This investigational therapy could represent a pioneering advance in transplant immunology by offering a disease-modifying option for chronic rejection.

6.    Povorcitinib Shows Promise in Phase 3 Trials for Hidradenitis Suppurativa

Incyte Corporation shared favorable Phase 3 data from the STOP-HS1 and STOP-HS2 trials for povorcitinib (INCB54707), a selective JAK1 oral inhibitor. Patients with moderate-to-severe hidradenitis suppurativa showed a reduction in inflammatory nodules and abscesses within 12 weeks. With rapid pain relief and reduced flare frequency, the results laid the groundwork for regulatory submission, promising a potential in treating this chronic skin disease.

7.    Atea Advances Hepatitis C Therapy with Promising Phase 3 Trials

Atea Pharmaceuticals launched two pivotal global Phase 3 studies, evaluating a novel regimen that combined bemnifosbuvir and ruzasvir for chronic hepatitis C. Designed to challenge the sofosbuvir/velpatasvir standard, this combination targets non-cirrhotic patients with a shortened eight-week course. Early Phase 2 data showed a 98% virologic response rate, signaling a promising new approach to managing HCV with improved convenience and tolerability.

8.    Radiopharmaceutical Breakthrough in GEP-NETs Treatment

ITM Isotope Technologies completed its COMPETE Phase 3 trial of ITM-11 (n.c.a. 177Lu-edotreotide), targeting somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 delivered a median progression-free survival of 23.9 months versus 14.1 months with everolimus. With quarterly dosing and a strong safety profile, ITM-11 may become a cornerstone of GEP-NET management.

9.    Remibrutinib Shows Strong Promise in Advanced CSU Treatment Trials

Novartis reported promising outcomes from the REMIX-1 and REMIX-2 Phase 3 trials of Remibrutinib, an oral Bruton’s tyrosine kinase inhibitor for chronic spontaneous urticaria (CSU). The trials showcased rapid symptom control and persistent efficacy over 24 weeks, with a lesser adverse effects. Targeting histamine release pathways, the drug may offer potential relief for millions living with CSU, a distressing and often debilitating skin condition.

10.    Cebranopadol: A Promising Shift in Acute Pain Management

Tris Pharma’s cebranopadol continues to gain traction with positive results from its ALLEVIATE-2 Phase 3 trial for acute post-bunionectomy pain. The oral dual nociceptin/opioid receptor agonist significantly reduced pain intensity and decreased reliance on rescue medications. With an earlier success in abdominal surgery and lower abuse potential, cebranopadol may reshape the future of acute pain management.

11.    CTx-1301: A Promising ADHD Solution Nearing FDA Review

Cingulate revealed encouraging Phase 3 results for CTx-1301 (dexmethylphenidate), a novel, once-daily medication targeting attention-deficit/hyperactivity disorder (ADHD). Designed for sustained symptom control, CTx-1301 demonstrated a strong safety profile in pediatric, adolescent, and adult studies. The drug maintained efficacy without serious adverse events and performed consistently, even with food intake. By eliminating the need for booster doses, CTx-1301 could revolutionize ADHD management.

12.    Rusfertide Shows Promise in Phase 3 Study for Polycythemia Vera

Protagonist Therapeutics, in collaboration with Takeda, released Phase 3 VERIFY trial results for rusfertide in polycythemia vera. This hepcidin mimetic peptide achieved all primary endpoints, significantly reducing phlebotomy requirements while keeping hematocrit levels under control. With a 77% response rate compared to 33% on placebo, rusfertide could redefine care for this chronic hematologic disease.

The continuous progress underscores a transformative period in drug development characterized by scientific innovation, therapeutic diversity, and a patient-centered approach. These late-stage clinical trials illustrate the potential for a meaningful impact across oncology, infectious diseases, immunology, psychiatry, and pain management. As many of these therapies approach regulatory milestones, they promise to shape the future of medicine and deliver new hope to millions worldwide.