Clinical trial coverage on Peptide News Digest pulls in Phase 1 through Phase 3 readouts across the peptide universe — GLP-1 obesity and cardiometabolic trials (SELECT, SURMOUNT-4, ACHIEVE-3, REDEFINE-1, SYNCHRONIZE-1), peptide vaccine work (AMPLIFY-201, MEL39), peptide-drug conjugate trials, and antimicrobial peptide programs.
Most of the noise sits with Lilly and Novo, but the interesting reads are usually elsewhere: Bicycle Therapeutics on solid tumors, Lirum on Ewing sarcoma, Cerapedics on lumbar fusion, Pelage on hair loss. Real-world evidence and registry data also land here when they reframe what the randomized trials showed.
Each entry names the sponsor, the phase, and the endpoint. Browse the latest below, or jump to the readouts by drug at #semaglutide, #tirzepatide, or #orforglipron.
Sanofi announced April 22 FDA approval of an expanded Tzield (teplizumab-mzwv) indication for stage 2 type 1 diabetes patients as young as 1 year old, down from the previous 8-and-up indication. The approval was supported by 1-year data from the PETITE-T1D Phase 4 study (n=23, mean age 4.8 years), showing 89.6% probability of remaining stage-3-progression-free at 1 year. Tzield delays progression from stage 2 to stage 3 T1D by an average of 2 years and is the first disease-modifying therapy for autoimmune T1D — relevant to the broader insulin/peptide endocrinology landscape.
Novo Nordisk announced April 23 positive topline results from the PIONEER TEENS trial: a 52-week, randomized, double-blind, placebo-controlled Phase 3a study of oral semaglutide (3, 7, or 14 mg once daily) in 132 children and adolescents aged 10-17 with type 2 diabetes. Oral semaglutide reduced HbA1c by 0.83 percentage points more than placebo at 26 weeks with a well-tolerated safety profile. Pending regulatory approvals, it would be the first oral GLP-1 RA for this pediatric population. Novo expects to file for label expansion in the US and EU in H2 2026.
Fractyl Health's REMAIN-1 study — the first blinded, randomized, sham-controlled trial of an endoscopic 'gut reset' procedure — was accepted for presentation at DDW 2026. In 45 adults who had lost ≥15% body weight on tirzepatide and then discontinued, 29 received Revita duodenal mucosal resurfacing and 16 had a sham procedure. At 6 months post-discontinuation, Revita-treated patients regained 4.5% vs 7.5% for sham (P=0.07) — a 40% lower weight regain. Patients with more tissue resurfaced maintained >80% of pre-discontinuation weight loss. Topline pivotal-cohort data expected Q4 2026.
Bicycle Therapeutics announced April 21 its program for the 2026 ASCO Annual Meeting (May 29-June 2 in Chicago), with an oral presentation and five poster abstracts on nuzefatide pevedotin — its EphA2-targeting bicyclic peptide drug conjugate. Key data from Phase 1/2 include the recently disclosed 40% ORR in checkpoint-refractory urothelial cancer, expanded head-and-neck squamous cell carcinoma preclinical data, and the selected 8mg/m² Q2W dose for the Phase 2 recurrent pancreatic cancer trial. The program solidifies Nuzefatide's positioning as a leading bicyclic peptide drug conjugate in oncology.
On the final day of AACR 2026, the German Cancer Consortium presented first-in-human imaging data for EphA2 BIA — a gallium-68-labeled bicyclic peptide targeting EphA2 — in pancreatic ductal adenocarcinoma patients. Seven patients underwent PET/CT imaging up to three hours post-injection, with rapid tumor uptake and primarily renal excretion in six of seven. The tracer successfully detected liver, bone, lymph node, and peritoneal metastases in 15 of 18 patients imaged to date, validating bicyclic peptides as a radioconjugate imaging modality.
Neurocrine Biosciences announced April 22 two-year data from the Phase 3 CAHtalyst Adult study at AACE 2026 in Las Vegas. CRENESSITY (crinecerfont), a CRF1 receptor antagonist that dampens the CRF-ACTH peptide signaling axis, achieved sustained glucocorticoid dose reductions in adults with classic congenital adrenal hyperplasia: mean daily GC dose decreased from 17.6 to 10.6 mg/m²/day HCe (−38%), and approximately 69% of patients achieved GC doses within the physiologic range while maintaining androgen control. No new safety signals emerged.
Evaxion's AI-designed personalized neoantigen peptide vaccine EVX-01 combined with Keytruda produced a 75% objective response rate at 2 years in advanced melanoma patients, with 86% of vaccine targets triggering de novo T-cell responses. Data were presented April 22 at AACR 2026; 3-year follow-up expected in H2 2026. The 86% target-hit rate demonstrates AI-designed peptide neoantigen selection maturing for cancer vaccines.
IQVIA tracking data reported April 21 showed Eli Lilly's newly-launched oral GLP-1 Foundayo (orforglipron) drew 1,390 prescriptions in its first full week (April 6-10), roughly 45% of the 3,071 Wegovy pill scripts in Novo Nordisk's launch week in January. Analyst consensus requires Foundayo to hit about 5.4 million prescriptions from April-December to generate $1.7 billion in 2026 revenue — a target that looks challenging at the current trajectory.
Perspective Therapeutics' [212Pb]VMT-α-NET, a first-in-class alpha-emitter peptide radionuclide therapy targeting SSTR2, achieved objective responses in 10 of 23 (43%) Cohort 2 patients with metastatic neuroendocrine tumors in Phase 1/2a data presented at AACR 2026. 18 of 25 patients (72%) remained alive without progression; no dose-limiting toxicities or Grade 4/5 adverse events observed.
Sapience Therapeutics presented first Phase 2 clinical data from ST316, a first-in-class β-catenin/BCL9 antagonist SPEAR peptide, in second-line metastatic colorectal cancer at AACR 2026. Dose expansion showed a well-tolerated safety profile with no dose-limiting toxicities or related SAEs, significant knockdown of Wnt-related signatures in tumor cells, and dose-proportional PK achieving predicted efficacious exposures.
Asahi Kasei initiated a Phase I trial in Japan of AK1940, a selective TNF receptor 1 antagonist peptide discovered jointly with PeptiDream for autoimmune and inflammatory diseases. The trial will assess PK, safety, and tolerability of single and multiple subcutaneous doses in healthy volunteers; preclinical models showed high TNFR1 selectivity and anti-inflammatory activity without blocking TNFR2 signaling.
The first definitive Phase 3B head-to-head trial of Lilly's tirzepatide versus Novo Nordisk's semaglutide in 750 patients with obesity over 72 weeks showed tirzepatide produced 21.6% mean weight loss vs semaglutide's 15.4%. 36.2% of tirzepatide patients achieved ≥25% weight loss vs 19.4% on semaglutide. Results published April 20 give Lilly a clear comparative data point in the GLP-1 market share battle.
Bicycle's EphA2-targeting bicyclic peptide-drug conjugate nuzefatide pevedotin (BT8009) at 6.5 mg/m² Q2W plus nivolumab achieved 40% confirmed ORR (4/10) in metastatic urothelial patients who had progressed on checkpoint inhibitors, and 100% (3/3) in MMAE-naive EphA2+ patients. No Grade ≥3 treatment-related adverse events of clinical interest. Presented at AACR 2026 on April 20.
Greenwich LifeSciences presented FLAMINGO-01 Phase III open-label data at AACR 2026 showing GLSI-100 (the 9-amino-acid GP2 HER2 peptide plus GM-CSF adjuvant) produced a ~4x increase in delayed-type hypersensitivity to GP2 across 247 non-HLA-A*02 patients — from 5.2% at baseline to 20.4% at months 4-6 (p<0.001). GP2 is the C-terminal transmembrane fragment of the HER2/neu protein.
BriaCell's Bria-IMT + checkpoint inhibitor combination preserved overall health status and key functional quality-of-life measures in its pivotal Phase 3 study in heavily pretreated metastatic breast cancer patients who had failed ADC, CPI, and CDK4/6 inhibitor therapy. Phase 2 biomarker analyses identified mitotic circulating tumor cells as prognostic and PD-L1 in tumor-macrophage fusion cells as predictive of checkpoint benefit. Presented at AACR April 20.
Enara Bio presented ENA101 at AACR 2026 on April 20, a first-in-class bispecific T-cell engager targeting DARKFOX — a novel cancer-specific 'dark antigen' peptide presented by HLA-A*03:01 and expressed in multiple solid tumors. Preclinical data showed low-picomolar potency and complete tumor regression in xenograft models with once-weekly dosing. IND submission planned for 2H 2026.
Circle Pharma presents early clinical data for CID-078 in the AACR 2026 Clinical Trials Plenary (Sunday, April 19, 1:00-3:00 PT). CID-078 is a first-in-class orally bioavailable macrocyclic peptide cyclin A/B RxL inhibitor evaluated in a Phase 1 multicenter trial (NCT06577987) for advanced solid tumors with RB1 alterations. The plenary slot — a coveted showcase for private biotechs — tests whether macrocyclic peptides can establish themselves as a third modality alongside small molecules and biologics.
Fedora Pharmaceuticals presented eight posters at ESCMID Global 2026 in Munich today highlighting FPI-2119, a first-in-kind derivative of the lactivicin class for Gram-negative infections. As a non-β-lactam antibiotic, FPI-2119 is not susceptible to β-lactamases. Posters demonstrated concentration-dependent bactericidal activity and low resistance frequency against Pseudomonas aeruginosa, maintained activity against β-lactamase-expressing E. coli strains, and activity against resistant Campylobacter, Salmonella, and Shigella.