Trial Watch; March Edition 6
U.S. Clinical Trial Announcements
This period shows strong momentum in precision oncology, rare disease, pulmonary disease, and cardiometabolic development. The biggest themes are targeted protein degradation in cancer, inhaled reformulations for lung disease, orally delivered metabolic and rare disease therapies, and pivotal or near-pivotal studies moving forward with clearer timelines and enrollment plans.
Therapeutic Areas Covered
Cardiometabolic
1 trialMIST Phase 2a; ECC4703 as Adjunct to Semaglutide for Obesity
Oral adjunct to once-weekly semaglutide to improve weight loss and metabolic measures beyond GLP-1 therapy alone
Timeline / Sites
Reported 16 March 2026. The study is a multicenter, randomized, double-blind, placebo-controlled Phase 2a trial expected to enroll about 160 adults with obesity. Treatment duration is 12 weeks.
What's New
ECC4703 is being studied as an oral adjunct to once-weekly semaglutide, with the goal of improving weight loss and other metabolic measures beyond GLP-1 therapy alone.
Why It Matters
This is a meaningful combination strategy in obesity. It tests whether an oral add-on can deepen or improve the quality of response on top of semaglutide, which is highly relevant for the next wave of obesity treatment development.
Oncology
4 trialsBTX-9341-101 Dose Expansion; CDK4/6 Degrader for HR+/HER2− Breast Cancer
First-in-class oral CDK4 and CDK6 degrader studied with fulvestrant after prior CDK4/6 inhibitor therapy
Timeline / Sites
Reported 18 March 2026. The randomized dose expansion portion is underway at multiple United States sites and is expected to enroll about 80 patients across two treatment arms.
What's New
BTX-9341 is a first-in-class oral CDK4 and CDK6 degrader being studied with fulvestrant in HR-positive HER2-negative breast cancer after prior CDK4 and CDK6 inhibitor therapy.
Why It Matters
This is an important resistance-focused breast cancer study. Instead of inhibiting CDK4 and CDK6, the drug degrades them, which could help overcome mechanisms that limit currently approved inhibitors.
Cemsidomide + Elranatamab Phase 1b; Relapsed/Refractory Multiple Myeloma
Oral IKZF1/IKZF3 degrader combined with BCMA×CD3 bispecific antibody to deepen immune-mediated anti-myeloma activity
Timeline / Sites
Reported 25 March 2026. This open-label multicenter study will enroll up to 54 patients. Phase 1b data are anticipated in mid-2027.
What's New
Cemsidomide is an oral IKZF1 and IKZF3 degrader, combined with elranatamab, a BCMA and CD3 bispecific antibody, to deepen immune-mediated anti-myeloma activity.
Why It Matters
This is a strong example of a next-generation combination strategy in multiple myeloma, pairing targeted protein degradation with bispecific T-cell redirection.
TRI-611 Phase 1/2; ALK-Positive Non-Small Cell Lung Cancer
Oral, brain-penetrant molecular glue degrader targeting ALK fusion proteins via cereblon recruitment
Timeline / Sites
Reported 25 March 2026. The first patient had already been treated earlier in March 2026. The study is a global, first-in-human, open-label Phase 1 dose escalation followed by Phase 2 expansion.
What's New
TRI-611 is an oral, brain-penetrant molecular glue degrader that targets ALK fusion proteins by recruiting them to cereblon for degradation.
Why It Matters
This is one of the more notable molecular glue degradation programs in lung cancer and is specifically aimed at overcoming the limitations of ALK kinase inhibition after resistance emerges.
VISUALIZE 2; Abenacianine for Tumor Visualization During Lung Cancer Surgery
Tumor-activated intraoperative imaging agent that illuminates malignant tissue using near-infrared imaging
Timeline / Sites
Reported 17 March 2026. VISUALIZE 2 is a randomized, open-label, multicenter Phase 3 trial that will enroll 132 participants at 10 sites across the United States and Australia in 2026.
What's New
Abenacianine is a tumor-activated intraoperative imaging agent that illuminates malignant tissue during surgery using near-infrared imaging.
Why It Matters
This is a meaningful device and imaging-enabled surgical oncology study. It aims to improve real-time tumor localization during minimally invasive and robotic lung surgery, where surgeons cannot rely on direct palpation.
Rare Disease
1 trialEsprit; S-606001 for Late-Onset Pompe Disease
Oral substrate reduction therapy inhibiting glycogen synthase, added to standard enzyme replacement therapy
Timeline / Sites
Reported 19 March 2026. Esprit is a 52-week randomized, placebo-controlled, double-blind study enrolling adults across the United States, European Union, and United Kingdom.
What's New
S-606001 is an oral substrate reduction therapy intended to limit glycogen buildup by inhibiting glycogen synthase, and it is being added to standard enzyme replacement therapy.
Why It Matters
This program could become the first oral substrate reduction therapy for Pompe disease and offers a differentiated mechanism that complements existing enzyme replacement approaches.
Pulmonary & Rare Respiratory Disease
1 trialAURA; AP02 Inhaled Nintedanib for Idiopathic Pulmonary Fibrosis
Inhaled nintedanib delivered by nebulization to improve lung targeting while reducing systemic exposure
Timeline / Sites
Reported 23 March 2026. AURA is a randomized, double-blind, placebo-controlled Phase 2 study expected to enroll 160 patients with idiopathic pulmonary fibrosis who are not currently on treatment. Primary endpoint is change in forced vital capacity at Week 12.
What's New
AP02 is inhaled nintedanib delivered by nebulization to improve lung targeting while reducing systemic exposure.
Why It Matters
Inhaled delivery could preserve antifibrotic benefit while improving tolerability versus oral nintedanib, which is a major clinical issue in pulmonary fibrosis care.
Metabolic & Endocrine
1 trialLUCIDITY; Avexitide for Post-Bariatric Hypoglycemia
First-in-class GLP-1 receptor antagonist intended to reduce severe hypoglycemic events after bariatric surgery
Timeline / Sites
Reported 24 March 2026. LUCIDITY enrolled 78 participants across 21 United States sites. The trial includes up to a 6-week screening period, a 16-week double-blind treatment period, and a 32-week open-label extension.
What's New
Avexitide is a first-in-class GLP-1 receptor antagonist intended to reduce severe hypoglycemic events in post-bariatric hypoglycemia.
Why It Matters
There are currently no FDA-approved therapies for post-bariatric hypoglycemia. Completion of enrollment in a pivotal Phase 3 trial makes this one of the clearest late-stage metabolic stories in the period.
Sleep Medicine
1 trialDReAMzz; IHL-42X for Obstructive Sleep Apnea
Oral fixed-dose combination of dronabinol and acetazolamide for dose optimization before Phase 3
Timeline / Sites
Reported 18 March 2026. Incannex states patient dosing is expected to begin within the coming months, after CRO appointment and site recruitment.
What's New
IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide intended to optimize both objective physiologic endpoints and patient-reported outcomes before an optimized Phase 3 program.
Why It Matters
This is a notable late mid-stage sleep medicine program because the company had positive Phase 2 data already and is deliberately running a crossover optimization study to strengthen the registrational pathway before Phase 3.
Emerging Trends
Targeted Protein Degradation in Cancer
Multiple programs this period; BTX-9341 (CDK4/6 degrader), cemsidomide (IKZF1/3 degrader), and TRI-611 (ALK molecular glue degrader); underscore a growing wave of degrader-based oncology therapies moving from preclinical promise into clinical expansion.
Inhaled Reformulations for Lung Disease
Avalyn's AP02 inhaled nintedanib for IPF highlights a broader trend of reformulating proven systemic therapies into inhaled delivery to improve tolerability and lung targeting.
Oral Therapies for Rare & Metabolic Disease
Shionogi's oral substrate reduction therapy for Pompe disease and Eccogene's oral obesity adjunct signal a shift toward patient-friendly oral dosing in traditionally injection-dominated therapeutic areas.
Pivotal Programs with Clear Registrational Paths
Multiple Phase 3 and near-pivotal studies; LUCIDITY, VISUALIZE 2, DReAMzz; are advancing with completed enrollment or defined timelines, reflecting sponsor confidence and late-stage momentum.
About Trial Watch
Trial Watch is Kitsa's bi-weekly overview of early-phase clinical trial activity, tracking new study initiations, first-patient dosing, and data that may shape future trial design and execution.
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