Trial Watch; May Edition 10
Where Conviction Is Building, In Real Time
The second half of May 2026 is defined by internal cannibalization at scale. Novo Nordisk simultaneously opened two mega-Phase 3 obesity programs running its next-generation assets against its own approved Wegovy/Ozempic franchise; CagriSema vs. Semaglutide (2,500 patients, 303 sites) and AMAZE 8 (NNC0487-0111 vs. Semaglutide, 1,000 patients, 120 sites). Janssen did the same in IBD: JNJ-78934804 vs. Guselkumab in parallel Crohn's and UC Phase 3 programs. Underneath it all, Regeneron's ROXI-PALISADE FXI-inhibitor program enrolls 7,050 patients; one of the largest cardiovascular outcomes Phase 3s in flight anywhere.
Therapeutic Areas Covered
Oncology
5 trialsMK-1045 vs. Blinatumomab in CD19+ B-Cell Acute Lymphoblastic Leukemia
Merck's CD19xCD3 bispecific challenges Amgen's blinatumomab franchise head-on
Timeline
Start: May 18, 2026. Primary completion: February 2029.
Mechanism
MK-1045 is Merck's CD19-directed bispecific T-cell engager, run head-to-head against Amgen's blinatumomab (the original CD19xCD3 BiTE and current standard of care in r/r B-ALL).
Why It Matters
Direct active-comparator Phase 2/3 against an established blockbuster BiTE. Merck is challenging Amgen's franchise asset head-on. If MK-1045 delivers superior efficacy or improved CRS/ICANS safety, blinatumomab's two-decade dominance in CD19 B-ALL ends.
Reference layer
ANKTIVA (Nogapendekin Alfa Inbakicept) + SOC vs. SOC in 1L Advanced/Metastatic NSCLC
IL-15 receptor agonist expands from bladder cancer into front-line NSCLC
Timeline
Start: May 29, 2026. Primary completion: May 2029.
Mechanism
Nogapendekin alfa inbakicept (N-803, ANKTIVA) is an IL-15 receptor agonist; approved in BCG-unresponsive NMIBC with CIS. This program moves the asset into a much larger indication: front-line advanced NSCLC in combination with pembrolizumab and platinum chemotherapy.
Why It Matters
ImmunityBio running ANKTIVA expansion at two indications simultaneously (NMIBC head-to-head from Edition 9 and now 1L NSCLC). If the NSCLC readout adds an IL-15 component to the IO + chemo backbone with clean safety, ANKTIVA becomes a foundational immunotherapy adjunct rather than a bladder-only specialty product.
Reference layer
[212Pb]Pb-MP0712; DLL3-Targeted Alpha-Emitter Radiopharmaceutical in DLL3+ Solid Tumors
First DLL3 alpha-particle radiopharmaceutical in clinical development
Timeline
Start: May 18, 2026. Primary completion: September 2028.
Mechanism
A DARPin-DOTAM construct (MP0712) loaded with Lead-212, a high-LET alpha-particle emitter. The first DLL3-targeted alpha-radiopharmaceutical in clinical development. Phase 1 inclusion rationale: first-in-class DLL3 alpha-emitter; novel modality on a clinically validated target.
Why It Matters
DLL3 is now a three-modality target. Amgen's tarlatamab (BiTE) is approved. Novartis's DJI136 DLL3 CAR-T (Edition 9) just entered Phase 1/2. Now Molecular Partners adds a 212Pb alpha-particle radiopharmaceutical. The DLL3 target stack is now deeper than any single-target portfolio in solid tumors.
Reference layer
REGN15505; PSMAx4-1BB Bispecific Antibody; Monotherapy and in Combination
Tumor-localized 4-1BB costimulation revives a class once defined by liver toxicity
Timeline
Start: May 25, 2026. Primary completion: September 2030.
Mechanism
REGN15505 is a PSMAx4-1BB bispecific antibody; combining tumor-localized PSMA binding with conditional 4-1BB costimulation only at the tumor site. Tested alone, with cemiplimab (anti-PD-1), and with REGN4336 (Regeneron's PSMAxCD3 BiTE) in mCRPC and clear cell RCC.
Why It Matters
4-1BB costimulation was a major immuno-oncology disappointment in the 2010s (urelumab, utomilumab) because of liver toxicity from systemic agonism. The tumor-localized bispecific approach re-opens 4-1BB as a tractable target. If REGN15505 delivers durable responses in late-line prostate cancer or RCC, the entire 4-1BB era restarts under bispecific architecture.
Reference layer
TeLuRide-008; EIK1001 + Pembrolizumab + Chemotherapy in Stage 4 NSCLC
Eikon's high-conviction bet that systemic TLR7/8 agonism finally works
Timeline
Start: May 18, 2026. Primary completion: December 2035.
Mechanism
EIK1001 is Eikon Therapeutics' TLR7/8 agonist designed to drive systemic innate-immune activation that primes adaptive antitumor responses. The trial combines it with the pembrolizumab + platinum doublet standard in 1L Stage 4 NSCLC.
Why It Matters
TLR agonists have been clinically frustrating for two decades. Eikon (the Roy Vagelos / Roger Perlmutter biotech) is the highest-conviction shot at making a systemic TLR7/8 agonist work in oncology. A 750-patient seamless Phase 2/3 means Eikon is operating with Phase 3-grade conviction; the readout determines whether TLR agonism as a class survives.
Reference layer
Cardiometabolic
5 trialsCagriSema vs. Semaglutide; Phase 3 in Obesity With or Without Type 2 Diabetes
2,500 patients across 303 sites; Novo's next-gen combo against its own Wegovy/Ozempic franchise
Timeline
Start: May 21, 2026. Primary completion: February 2028.
Mechanism
CagriSema is Novo's fixed-dose combination of cagrilintide (a long-acting amylin analog) with semaglutide. This Phase 3 directly compares two doses of CagriSema against semaglutide alone.
Why It Matters
Novo running its next-generation combination against its own approved Wegovy/Ozempic blockbuster; at 2,500 patients and 303 sites globally. After the December 2024 CagriSema disappointment, this re-test at a larger comparator scale is Novo's bid to demonstrate the amylin+GLP-1 combination's real-world superiority. Eli Lilly's retatrutide and Roche's CT-996 are watching closely.
Reference layer
AMAZE 8; NNC0487-0111 vs. Semaglutide in Obesity With Type 2 Diabetes
Third concurrent Phase 3 for Novo's successor obesity asset; head-to-head against semaglutide
Timeline
Start: May 20, 2026. Primary completion: December 2028.
Mechanism
The third AMAZE program for NNC0487-0111 (after Edition 8's AMAZE 12 in obesity and Edition 9's AMAZE 4 in obesity + OSA). Comparator: semaglutide head-to-head in obesity with T2D.
Why It Matters
Three concurrent Phase 3s for the same Novo asset; one general obesity (placebo-controlled), one OSA-specific, one T2D head-to-head against Novo's own semaglutide. Novo is engineering its successor asset to enter the market with three indication-specific labels and internal head-to-head wins versus Wegovy; protecting franchise economics from semaglutide patent exposure in 2030+.
Reference layer
Maridebart Cafraglutide; Switching From GLP-1 Receptor Agonists to MariTide in Obesity
First explicit Phase 3 designed for the post-GLP-1-switch market
Timeline
Start: May 25, 2026. Primary completion: January 2028.
Mechanism
Maridebart Cafraglutide (MariTide / AMG 133) is Amgen's monthly-dosed GLP-1R agonist + GIP receptor antagonist conjugate. This Phase 3 specifically enrolls patients already on semaglutide or tirzepatide who switch to MariTide.
Why It Matters
First explicit Phase 3 designed for the post-GLP-1-switch market. With ~10M patients globally on Wegovy/Ozempic/Mounjaro/Zepbound, the durability of weight loss after switching to a longer-acting once-monthly is the real-world question that defines whether MariTide commands premium pricing. Amgen is the third major obesity entrant after Novo and Lilly.
Reference layer
ROXI-PALISADE; REGN7508 and REGN9933 (Anti-Factor XI) in Recent Lower Extremity Revascularization
7,050-patient master protocol; one of the largest cardiovascular outcomes Phase 3s in flight
Timeline
Start: May 29, 2026. Primary completion: August 2029.
Mechanism
Two parallel anti-Factor XI monoclonal antibodies (REGN7508 and REGN9933) tested against placebo and rivaroxaban in patients with recent lower extremity revascularization for symptomatic PAD. Factor XI inhibition is the next-generation antithrombotic thesis; anticoagulation without the bleeding penalty.
Why It Matters
One of the largest cardiovascular outcomes Phase 3s in flight anywhere; 7,050 patients. Factor XI is the most contested next-gen anticoagulant target, with Bayer/Janssen (asundexian), BMS/J&J (milvexian), and Anthos (abelacimab) all in late-stage development. Regeneron entering with two parallel antibody candidates in the same master protocol signals confidence the FXI thesis holds.
Reference layer
VI-0106; Extended-Release Tacrolimus in Pulmonary Arterial Hypertension
First Phase 3 test of BMPR2-targeting immunomodulation in PAH
Timeline
Start: May 29, 2026. Primary completion: May 2028.
Mechanism
Extended-release tacrolimus (calcineurin inhibitor) targeting BMPR2 signaling restoration in PAH; a fundamentally different mechanism from vasodilators or PDGF-targeting agents. Patients enrolled have functional limitations despite optimized standard PAH therapy.
Why It Matters
PAH has been a vasodilator-dominated field. After Edition 8's Insmed Treprostinil Palmitil (PALM-PAH) and Regeneron's REGN13335 (ILLUMINATE, anti-PDGF-B), VIVUS is testing an immunomodulator. Tacrolimus's BMPR2 connection has been a 15-year preclinical thesis; this is the first Phase 3 test.
Reference layer
Immunology & Autoimmune
3 trialsJNJ-78934804 vs. Guselkumab; Parallel Phase 3 in Crohn's Disease and Ulcerative Colitis
Janssen runs two simultaneous Phase 3s against its own approved Tremfya franchise
Timeline
Both start May 29, 2026. Crohn's primary completion June 2028; UC primary completion August 2028.
Mechanism
JNJ-78934804 is Janssen's next-generation IBD asset, run directly head-to-head against guselkumab (Tremfya; Janssen's own approved IL-23p19 inhibitor, expanded for IBD in 2024). Two simultaneous Phase 3s; one in Crohn's, one in UC; both active-comparator vs. Tremfya.
Why It Matters
Continues the dominant 2026 pattern of sponsors running head-to-head trials against their own approved blockbusters. Janssen is running TWO Phase 3s against its own franchise IL-23 inhibitor in the same week. If JNJ-78934804 wins on deep remission or endoscopic outcomes, Tremfya's IBD lifecycle compresses. If Tremfya holds, Janssen has the cleanest possible data to defend the franchise into the late 2020s.
Mosunetuzumab in Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
CD20xCD3 bispecific T-cell engager crosses into autoimmune B-cell disease
Timeline
Start: May 25, 2026. Primary completion: February 2028.
Mechanism
Mosunetuzumab is Roche's CD20xCD3 bispecific T-cell engager; approved in follicular lymphoma since 2022. This Phase 2 moves it into systemic lupus erythematosus, including patients with active lupus nephritis. The autoimmune hypothesis: BiTEs can drive deep, transient B-cell depletion analogous to CAR-T without lymphodepletion or autologous manufacturing.
Why It Matters
The autoimmune B-cell modality stack is now four-deep: CD19 CAR-T (BMS Breakfree-SSc; Edition 8), mRNA CAR-T (Cartesian Descartes-08; Edition 8), BAFF/APRIL antagonism (Vertex povetacicept; Edition 8), and now CD20xCD3 BiTE (Roche mosunetuzumab in SLE). If mosunetuzumab delivers SRI/lupus-nephritis remission rates near CAR-T levels with an off-the-shelf protocol, it reframes the entire autoimmune CAR-T economic argument.
Reference layer
Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
UCB's FcRn inhibitor pursues the first biologic label specifically for ocular MG
Timeline
Start: May 29, 2026. Primary completion: December 2028.
Mechanism
Rozanolixizumab (Rystiggo) is UCB's approved FcRn inhibitor for generalized myasthenia gravis. This Phase 3 expands the label to ocular myasthenia gravis; a previously underserved subtype.
Why It Matters
Ocular MG has lacked dedicated Phase 3 evidence for biologics; most patients receive off-label oral immunosuppression. A successful Phase 3 here positions Rystiggo as the first biologic specifically labeled for OMG. UCB competing here against argenx's Vyvgart franchise and Vertex's povetacicept (Edition 8).
Reference layer
Neurology
2 trialsVGN-R08b; AAV Gene Therapy in Parkinson's Disease Patients With GBA1 Mutations
First AAV gene replacement therapy in clinic for genetic Parkinson's
Timeline
Start: May 25, 2026. Primary completion: September 2027.
Mechanism
AAV-delivered gene replacement therapy for patients with GBA1 mutations (the most common genetic risk factor for Parkinson's, accounting for 5 to 10% of cases). Delivered via intracerebroventricular injection across three escalating dose cohorts. Phase 1 inclusion: first AAV gene therapy for genetic Parkinson's; novel modality on a genetically validated target.
Why It Matters
GBA1-Parkinson's is one of the cleanest gene therapy targets in neurology; monogenic, defined patient cohort, established biomarker. Multiple GBA1 small molecules have failed (Lysosomal Therapeutics' venglustat). VGN-R08b is the first AAV gene replacement reaching clinic. If successful, it validates monogenic PD as a gene-therapy-tractable category.
Reference layer
Colchicine 0.5 mg Once Daily in Spontaneous Intracerebral Hemorrhage With Atherosclerotic Risk
PHRI tests the LoDoCo anti-inflammatory thesis in post-ICH stroke recovery
Timeline
Start: May 30, 2026. Primary completion: July 2028.
Mechanism
Low-dose oral colchicine (anti-inflammatory, NLRP3-inflammasome inhibitor) administered to patients after spontaneous intracerebral hemorrhage with established or risk factors for atherosclerosis. Tests whether sustained anti-inflammation reduces dependency and recurrent cardiovascular events.
Why It Matters
Colchicine's LoDoCo / CONVINCE / COLCOT cardiovascular data established the anti-inflammatory thesis in atherosclerotic disease. Extending it to post-ICH is novel; most cerebrovascular trials focus on reperfusion or hematoma expansion, not inflammation. PHRI (the Salim Yusuf group) has produced some of the highest-quality cardiovascular Phase 3s of the last two decades.
Reference layer
Advanced Modalities
1 trialNAAVIGATE; Surabgene Lomparvovec (Sura-vec) via Suprachoroidal Injection in Diabetic Retinopathy Without CI-DME
576-patient seamless Phase 2b/3; one of the largest AAV gene therapy trials in any indication
Timeline
Start: May 20, 2026. Primary completion: June 2028.
Mechanism
Surabgene Lomparvovec (Sura-vec) is an AAV gene therapy delivering an anti-VEGF transgene via suprachoroidal space injection; a single-administration approach designed to replace the chronic intravitreal injection burden of aflibercept/ranibizumab/bevacizumab. Targets diabetic retinopathy without center-involved diabetic macular edema (early disease setting).
Why It Matters
One of the largest AAV gene therapy trials in any indication; 576 patients in an operationally seamless 2b/3 design. AbbVie inherited the Allergan retinal portfolio and is now staking its position in retinal gene therapy alongside Regenxbio (ABBV-RGX-314) and 4D Molecular Therapeutics. Diabetic retinopathy is a 9.6M-patient indication globally; even modest market penetration with a one-time gene therapy is meaningful.
Reference layer
Signal Convergence
The obesity head-to-head era arrives; at internal cannibalization scale
Novo Nordisk staged two mega Phase 3 head-to-heads in the same window; CagriSema vs. Semaglutide (2,500 patients, 303 sites) and AMAZE 8 (NNC0487-0111 vs. Semaglutide, 1,000 patients); both testing next-generation Novo assets against Novo's own approved Wegovy/Ozempic franchise. Amgen entered with a Phase 3 switch trial for MariTide. The obesity field has moved past 'does GLP-1 work' into 'which sponsor cannibalizes their own franchise first, on their own terms.'
DLL3 becomes a three-modality battleground
Tarlatamab (Amgen BiTE) is approved. Edition 9's DJI136 (Novartis CAR-T) just opened. Edition 10 adds Molecular Partners' [212Pb]Pb-MP0712; the first DLL3 alpha-particle radiopharmaceutical. Three fundamentally different therapeutic engines on the same DLL3 epitope. No solid-tumor target has ever had this stack depth at once.
Bispecific T-cell engagers cross into autoimmune disease
Roche's mosunetuzumab (CD20xCD3, approved in follicular lymphoma) enters Phase 2 in SLE / lupus nephritis. The autoimmune B-cell modality stack is now four-deep: CAR-T (BMS Breakfree-SSc), mRNA CAR-T (Cartesian Descartes-08), BAFF/APRIL antagonism (Vertex povetacicept), and now CD20xCD3 BiTE (Roche).
AAV gene therapy reaches Phase 2b/3 in two new high-volume indications
AbbVie's NAAVIGATE moves Surabgene Lomparvovec into 576-patient Phase 2b/3 in diabetic retinopathy. Shanghai Vitalgen's VGN-R08b becomes the first AAV gene therapy in clinic for genetic Parkinson's. Two new categorical wins for the modality in the same two-week window.
Mega-trials reappear
Regeneron's ROXI-PALISADE (7,050 patients), Novo's CagriSema (2,500), AMAZE 8 (1,000), NAAVIGATE (576). Big pharma is committing serious operational capital again.
On Verification
Every trial in this edition is anchored to deterministic, verifiable sources sitting inline under each entry: the trial's ClinicalTrials.gov record (verified at compile time), its WHO ICTRP cross-listing (deterministic URL pattern, registry redundancy), and the sponsor's evergreen clinical trials search portal where available. Dated press-release URLs are intentionally not embedded inline because they 404 over time; the verified registry and portal links above are stable. All 16 trials in this edition have start dates verified to fall within May 16 to May 31, 2026, and none repeat from Editions 1 to 9.
About Trial Watch
Trial Watch is Kitsa's clinical intelligence layer. It captures high-signal clinical trial events and interprets where science, capital, and strategy are converging.
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