Search only the reports published on VALREXA. This is not a live web search; reports link to their original sources.
Stages describe the linked report, not a continuously monitored regulatory record. Dates identify the report, source edition or original approval event. A trial announcement is not a positive result, and an approval applies only to its specified indication and jurisdiction.
Planned study at the Medical University of Warsaw, Poland · Peer-reviewed randomized-study protocol (Frontiers in Oral Health)
Stage at report: Published randomized-study protocol; not reported treatment results (Frontiers in Oral Health)
Intervention: Dentist-applied P11-4 with fluoride varnish; single versus repeated application and fluoride varnish alone
Studied for / scope: Early enamel carious white-spot lesions; planned enrollment of 75 young people (Frontiers in Oral Health)
A study protocol published in Frontiers in Oral Health describes a randomized trial examining P11-4, a self-assembling peptide used to support mineral repair in early tooth-decay lesions. The planned study would compare single and repeated applications of the peptide alongside fluoride varnish with fluoride varnish alone. (Published protocol)
The protocol describes a planned enrollment of 75 young people in Poland with active enamel white-spot lesions. It reports no trial results, so the publication should not be interpreted as proof that repeated treatment is superior or that the planned participants have already been enrolled. (Protocol methods and absence of results)
P11-4 provides a different approach from replacing lost tooth material with a filling: the peptide forms a scaffold intended to support mineral deposition within an early lesion. The manufacturer of Curodont Repair, vVARDIS, specifies early, non-cavitated lesions and states that the product does not fill existing cavities. (Mechanism review, professional product information)
Earlier clinical evidence is promising but requires qualification. A 2023 JADA systematic review of six trials found that Curodont Repair likely improved caries arrest and reduced lesion size, while also finding elevated risks of bias across the included trials and calling for longer studies. (JADA review)
These findings should not be presented as proof that a peptide can regrow an entire tooth, reliably replace treatment for a formed cavity or produce identical results across every branded formulation. In particular, the JADA review included no trials of Curodont Repair Fluoride Plus, and a separate 2026 study of an orthodontic prevention gel addressed a different use. (JADA formulation limits, professional treatment limits, separate prevention-gel trial)
Keep in mind: A published protocol describes a research plan, not a successful treatment outcome. This News item does not assert current recruitment status, completion or results, and it does not provide instructions for applying dental products. (Protocol’s stated study stage)
Peptide relevance: P11-4 is an actual peptide, and its proposed function is directly related to peptide self-assembly and biomaterials science. It broadens the website’s peptide focus into dentistry without turning a promising treatment into a claim of unlimited tooth regeneration. (Peer-reviewed molecular and mechanism review, clinical evidence review)
Source checked by site editor: 2026-11-08. Editorial review is not independent clinical validation.
Full P11-4 collection profile
U.S. regulatory milestones; a planned U.S. Phase 2 combination study. SUPREME-01 has a separate registry site list. · Company announcement of clinical-development milestones (Caliway Biopharmaceuticals via PR Newswire)
Stage at report: Phase 3 enrollment milestone and separate Phase 2 trial authorization (Caliway Biopharmaceuticals via PR Newswire)
Intervention: CBL-514; CBL-514 plus tirzepatide in a separate study
Studied for / scope: Localized abdominal subcutaneous fat reduction; the separate combination study concerns overweight or obese adults (Caliway Biopharmaceuticals via PR Newswire)
Caliway Biopharmaceuticals announced two development milestones for CBL-514, its investigational small-molecule injection for localized fat reduction. The company said enrollment had begun in SUPREME-01, a pivotal Phase 3 study evaluating abdominal fat reduction, after U.S. ethics-board approval of a protocol amendment.
Separately, Caliway reported U.S. FDA clearance of the Investigational New Drug application for CBL-0201WR, a Phase 2 study combining CBL-514 with tirzepatide. That randomized, single-blind, placebo-controlled study was announced with an anticipated 120 participants in the United States and MRI measurements of abdominal subcutaneous fat.
The company is a Taiwan-based clinical-stage drug developer. CBL-514 is a small molecule, not a peptide; its separate combination program is relevant to peptide-based metabolic research because tirzepatide is a modified peptide targeting GIP and GLP-1 receptors. (Caliway Biopharmaceuticals via PR Newswire)
Keep in mind: The announcement describes permission to conduct research and a trial-enrollment milestone, not results proving that either program works. It does not establish marketing approval of CBL-514 or of the CBL-514–tirzepatide combination, and it reports no outcomes from either trial. (Caliway Biopharmaceuticals via PR Newswire)
Peptide relevance: The connection is the separate planned study with tirzepatide, not a claim that CBL-514 is a peptide. Coverage should remain labeled Related science and should not imply that the combination has already demonstrated benefit in people. (Caliway Biopharmaceuticals via PR Newswire)
Source checked by site editor: 2026-11-08. Editorial review is not independent clinical validation.
Supporting sources: Caliway company information · FDA tirzepatide background · Full CBL-514 collection profile
Multinational study; ClinicalTrials.gov NCT06878404 lists sites in the United States, Asia, Europe and elsewhere. · Company announcement of clinical trial results (Johnson & Johnson)
Stage at report: Phase 3 results reported by sponsor; investigational for psoriatic arthritis (Johnson & Johnson)
Intervention: Icotrokinra (ICOTYDE), an oral peptide that blocks the IL-23 receptor
Studied for / scope: Active psoriatic arthritis in adults who have not previously received biologic therapy (Johnson & Johnson)
Johnson & Johnson reported new results from ICONIC-PsA 1, a randomized trial comparing the oral peptide icotrokinra with placebo in adults with active psoriatic arthritis. At 16 weeks, 58% of participants in the reported icotrokinra group met ACR20, a standard measure of improvement in arthritis, compared with 41% receiving placebo. The findings were reported at the American College of Rheumatology's 2026 meeting. The new development concerns arthritis, not the medicine's existing US approval for plaque psoriasis. (Johnson & Johnson)
Keep in mind: These are sponsor-reported conference findings, and the announcement does not provide the trial's participant count or a full peer-reviewed report. Icotrokinra is not approved for active psoriatic arthritis according to the release. The week-16 response does not establish a cure or long-term safety. (Johnson & Johnson)
Peptide relevance: The source explicitly identifies icotrokinra as a targeted oral peptide. The update illustrates testing an orally delivered peptide against an inflammatory-disease target beyond its existing US psoriasis indication. (Johnson & Johnson)
Source checked by site editor: 2026-11-08. Editorial review is not independent clinical validation.
Study countries are not specified in the announcement; the sponsor is based in Denmark and the findings were announced for SITC in Phoenix, United States. · Company announcement of clinical biomarker findings (Evaxion)
Stage at report: Phase 2 biomarker update; sponsor-reported conference findings (Evaxion)
Intervention: EVX-01, a personalized peptide-based cancer vaccine studied with pembrolizumab
Studied for / scope: Advanced melanoma (Evaxion)
Evaxion reported new immune-system findings from its Phase 2 EVX-01 program in advanced melanoma. Researchers detected vaccine-targeted T cells directly in patient samples and reported an association between the platform's predicted vaccine targets and observed T-cell responses. EVX-01 is made from peptides selected for an individual patient's cancer. The November update concerns immune biomarkers; the clinical response figures discussed alongside it come from earlier follow-up, not a new randomized comparison. (Evaxion)
Keep in mind: The release describes earlier clinical responses in 16 patients but does not state the sample size for the new biomarker analysis. It provides no control-arm comparison or detailed new safety results. Patients received pembrolizumab during the first two years, so the reported clinical outcomes cannot be attributed to the vaccine alone. Immune responses do not by themselves prove a survival benefit. (Evaxion)
Peptide relevance: EVX-01 is explicitly described as a personalized peptide-based cancer vaccine. It uses selected tumor-associated targets to investigate whether peptide vaccination can direct an immune response against an individual's cancer. (Evaxion)
Source checked by site editor: 2026-11-08. Editorial review is not independent clinical validation.
China; GRADUAL-3 is part of the China-based Phase 3 GRADUAL program described by Gan & Lee. · Company announcement of clinical trial topline results (Gan & Lee Pharmaceuticals via PR Newswire)
Stage at report: Phase 3b maintenance study; sponsor-reported topline results (Gan & Lee Pharmaceuticals via PR Newswire)
Intervention: Bofanglutide (GZR18), a GLP-1 analogue
Studied for / scope: Weight maintenance in adults with obesity or overweight after prior active treatment (Gan & Lee Pharmaceuticals via PR Newswire)
Gan & Lee reported topline results from GRADUAL-3, testing whether monthly bofanglutide could maintain weight loss after participants completed 52 weeks of prior treatment. Over the subsequent 24 weeks, average body-weight changes were +0.41% and -0.12% in the two active-treatment groups, compared with +8.52% in the placebo group. The question here is maintenance of previously achieved weight loss, not how much weight an untreated person would lose when starting the medicine. The company said detailed results would be presented and submitted for journal publication later. (Gan & Lee Pharmaceuticals via PR Newswire)
Keep in mind: The announcement does not disclose participant numbers or confidence intervals, and a full peer-reviewed GRADUAL-3 report is not provided. Participants were eligible completers of an earlier treatment study, limiting generalization to everyone starting therapy. Gastrointestinal adverse events were reported. These findings do not establish an approved monthly treatment regimen. (Gan & Lee Pharmaceuticals via PR Newswire)
Peptide relevance: Peer-reviewed background research identifies GZR18, also called bofanglutide, as a GLP-1 analogue. The new trial addresses a practical development question for peptide-hormone-based metabolic medicines: maintaining an earlier treatment response. (Gan & Lee Pharmaceuticals via PR Newswire)
Source checked by site editor: 2026-11-08. Editorial review is not independent clinical validation.
Washington State University research program in the United States; this announcement does not report a human trial. · University research announcement (Washington State University)
Stage at report: Preclinical development; work to support a future human-trial application (Washington State University)
Intervention: Alphatide, a peptide designed to disrupt proteins involved in sperm development
Studied for / scope: Male contraception; no disease-treatment indication (Washington State University)
Washington State University reported a two-year grant supporting further preclinical development of Alphatide, a peptide-based male-contraceptive candidate. The planned studies will examine where the peptide goes in the body, how long it remains active and how it is cleared. The university describes earlier reversible contraceptive effects in mice, but the newly announced grant is intended to generate additional evidence before an application to begin human testing. This is an early peptide-development story, not an announcement of an available contraceptive. (Washington State University)
Keep in mind: No human trial, human efficacy result or human safety result is reported. The university article does not give detailed mouse-study methods, sample sizes or quantitative efficacy results. Reversibility observed in mice does not establish reversibility or safety in people. (Washington State University)
Peptide relevance: The university explicitly identifies Alphatide as a peptide, meaning a short chain of amino acids. Its proposed application is contraception, expanding this batch beyond metabolic and inflammatory-disease research. (Washington State University)
Source checked by site editor: 2026-11-08. Editorial review is not independent clinical validation.
Study countries are not specified in the announcement; the company's San Diego dateline is not used as a trial location. · Company announcement of clinical program initiation (Viking Therapeutics)
Stage at report: Phase 3 program initiation; no Phase 3 results in this announcement (Viking Therapeutics)
Intervention: Oral VK2735, a dual GLP-1/GIP receptor agonist
Studied for / scope: Obesity or overweight, in separate studies with and without type 2 diabetes (Viking Therapeutics)
Viking Therapeutics announced the start of its SUNRISE Phase 3 program for oral VK2735. Two randomized, placebo-controlled studies will each target enrollment of 560 adults and assess treatment over 68 weeks. One study includes adults without type 2 diabetes; the other includes adults with type 2 diabetes. Their main endpoint is percentage change in body weight. This announcement marks a move into larger trials, rather than a new Phase 3 efficacy result. (Viking Therapeutics)
Keep in mind: Enrollment targets are not completed-study participant counts, and the release provides no Phase 3 outcomes. Earlier Phase 2 weight-loss figures are not results from SUNRISE. The release describes gastrointestinal adverse events in the earlier program and does not establish approval of oral VK2735. (Viking Therapeutics)
Peptide relevance: The treatment targets the GLP-1 and GIP receptors named in the source, connecting the story directly to peptide-hormone signaling. It is labeled related science because this announcement does not itself specify the molecule's chemical class. (Viking Therapeutics)
Source checked by site editor: 2026-11-08. Editorial review is not independent clinical validation.
Global trial; UK milestone · Research institution (NIHR Leeds)
Stage at report: Phase 2/3 trial milestone (NIHR Leeds)
Intervention: Zaloganan, an investigational antimicrobial peptide
Studied for / scope: Prosthetic joint infection (NIHR Leeds)
The RETAIN trial treated its first three participants outside the US at Leeds, testing a peptide designed to tackle bacterial biofilms around replacement joints. (NIHR Leeds)
Keep in mind: This report describes recruitment and treatment milestones, not evidence that the peptide improves patient outcomes. (NIHR Leeds)
Democratic Republic of the Congo · Public-health organization (WHO)
Stage at report: Recommended trial additions; national approvals pending (WHO)
Intervention: ChAdOx1 and mRNA-1469 vaccine candidates
Studied for / scope: Ebola disease caused by Bundibugyo virus (WHO)
WHO expert groups recommended adding the Oxford/Serum Institute and Moderna candidates to the ongoing Tumaini ring-vaccination trial in the DRC. (WHO)
Keep in mind: Entry still awaits national approvals, and the announcement does not report vaccine efficacy results. (WHO)
Study location not stated in this report · Public research agency (NIH News in Health)
Stage at report: Laboratory study (NIH News in Health)
Intervention: Antibodies targeting allergy-related molecules
Studied for / scope: Alpha-gal syndrome (NIH News in Health)
Laboratory screening identified 13 antibodies that targeted molecules involved in the allergic response associated with tick-related red-meat allergy. (NIH News in Health)
Keep in mind: More research is needed to establish whether the antibodies can prevent allergic reactions in people. (NIH News in Health)
Study location not stated in this report · Public research agency (NIH News in Health)
Stage at report: Human brain-tissue study (NIH News in Health)
Intervention: No medicine tested; hippocampal tissue analysis
Studied for / scope: Depression (NIH News in Health)
Researchers found differences in the maturation of newly formed brain cells and in gene activity in tissue from donors with a history of depression. (NIH News in Health)
Keep in mind: This study does not demonstrate that a treatment works or establish that these changes cause depression. (NIH News in Health)
11 centers in China · Journal paper (Signal Transduction and Targeted Therapy)
Stage at report: Randomized Phase 2 results (Signal Transduction and Targeted Therapy)
Intervention: Pegylated liposomal doxorubicin with trastuzumab and pertuzumab
Studied for / scope: Stage II–III HER2-positive breast cancer (Signal Transduction and Targeted Therapy)
A concurrent chemotherapy and HER2-targeted regimen produced more pathological complete responses than the sequential comparator in this randomized trial. (Signal Transduction and Targeted Therapy)
Keep in mind: Event-free survival was not significantly different, and the authors call for Phase 3 confirmation because of study size, follow-up and generalizability limits. (Signal Transduction and Targeted Therapy)
United States · Professional association (NCPA)
Stage at report: Compounding policy report (NCPA)
Intervention: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500
Studied for / scope: Compounding policy, not a disease-specific efficacy finding (NCPA)
NCPA reported that FDA enforcement discretion would allow 503A pharmacies to compound the six listed peptide bulk substances. (NCPA)
Keep in mind: The report says final rulemaking is still pending and gives no duration for the discretion; it is not a drug-approval announcement. (NCPA)
Related collection profiles: BPC-157 · TB-500 · MOTS-c
UK, Germany and Spain · Research institution (NIHR Leeds)
Stage at report: Phase 1/2 trial milestone (NIHR Leeds)
Intervention: QEL-005 engineered regulatory T-cell therapy
Studied for / scope: Difficult-to-treat rheumatoid arthritis and systemic sclerosis (NIHR Leeds)
The CHILL study completed its first dose cohort and progressed to a second planned cohort following a safety review. (NIHR Leeds)
Keep in mind: The therapy remains investigational, and this announcement does not establish clinical benefit. (NIHR Leeds)
European Union regulatory review · Regulator (European Medicines Agency)
Stage at report: CHMP positive opinion at the report date (European Medicines Agency)
Intervention: Rasonque (daraxonrasib)
Studied for / scope: Previously treated metastatic pancreatic adenocarcinoma in adults (European Medicines Agency)
The CHMP recommended marketing authorisation after a phased review through EMA's Cancer Medicines Pathfinder project. (European Medicines Agency)
Keep in mind: A committee recommendation is not a European Commission authorisation; the linked October report lists that decision as pending. (European Medicines Agency)
European Union regulatory review · Regulator (European Medicines Agency)
Stage at report: CHMP positive opinion at the report date (European Medicines Agency)
Intervention: Foundayo (orforglipron)
Studied for / scope: Weight management and type 2 diabetes in adults (European Medicines Agency)
The CHMP recommended the once-daily oral GLP-1 receptor agonist for marketing authorisation. (European Medicines Agency)
Keep in mind: The linked report describes a committee recommendation, with the European Commission decision still pending at that date. (European Medicines Agency)
European Union regulatory review · Regulator (European Medicines Agency)
Stage at report: CHMP positive opinion at the report date (European Medicines Agency)
Intervention: Yuviwel (navepegritide)
Studied for / scope: Achondroplasia in children (European Medicines Agency)
The CHMP recommended marketing authorisation for the orphan-designated medicine. (European Medicines Agency)
Keep in mind: The October announcement is a recommendation rather than a report of final European Commission authorisation. (European Medicines Agency)
Australia, New Zealand and UK hospitals · Research institution (University of Melbourne)
Stage at report: Clinical trial launch; phase not stated (University of Melbourne)
Intervention: Caffeine citrate dosing regimens
Studied for / scope: Apnoea of prematurity (University of Melbourne)
The BabyCCINO trial will compare three commonly used caffeine doses and regimens to determine which best supports very preterm babies. (University of Melbourne)
Keep in mind: This is a launch announcement, not a report of results or a recommendation for an individual baby's dose. (University of Melbourne)
International science recognition · Official prize announcement (NobelPrize.org)
Stage at report: Foundational chemistry, not a medicine trial (NobelPrize.org)
Intervention: Non-linear effects and autocatalysis in asymmetric organic synthesis
Studied for / scope: Research methods relevant to pharmaceutical chemistry (NobelPrize.org)
Henri Kagan and Kenso Soai were recognized for discoveries that help explain and control how chemical reactions favor one molecular mirror image. (NobelPrize.org)
Keep in mind: This award recognizes foundational chemistry and does not announce an approved medicine or a clinical treatment result. (NobelPrize.org)
International science recognition · Official prize announcement (NobelPrize.org)
Stage at report: Foundational neuroscience, not a treatment approval (NobelPrize.org)
Intervention: Light-gated ion channels and optogenetics
Studied for / scope: Neuroscience and neural-circuit research (NobelPrize.org)
Karl Deisseroth, Peter Hegemann and Georg Nagel were recognized for discoveries enabling researchers to control selected nerve cells with light. (NobelPrize.org)
Keep in mind: The prize announcement describes a research method and does not establish a new broadly available treatment for neurological disease. (NobelPrize.org)
United States · Professional association (NCPA)
Stage at report: Advisory committee vote (NCPA)
Intervention: Six peptide bulk substances and emideltide
Studied for / scope: Compounding policy, not a clinical efficacy study (NCPA)
NCPA reports that the July advisory committee recommended six peptide substances for the 503A Bulks List and rejected emideltide. (NCPA)
Keep in mind: The same report states that pharmacies are still awaiting final rulemaking, so the advisory vote should not be described as a completed rule. (NCPA)
Democratic Republic of the Congo · Public-health organization (WHO)
Stage at report: Randomized adaptive platform trial; phase not stated (WHO)
Intervention: MBP134, remdesivir, and their combination
Studied for / scope: Ebola disease caused by Bundibugyo virus (WHO)
The PARTNERS trial began enrolling patients to test whether either antiviral approach, or both together, can improve survival. (WHO)
Keep in mind: This opening announcement reports no efficacy findings and states that these treatments are not approved for Bundibugyo virus disease. (WHO)
United States regulatory decision · Regulator (FDA Drug Trials Snapshots)
Stage at report: FDA-approved indication at original approval (FDA Drug Trials Snapshots)
Intervention: Decnupaz (pivekimab sunirine)
Studied for / scope: Blastic plasmacytoid dendritic cell neoplasm in adults (FDA Drug Trials Snapshots)
FDA's Drug Trials Snapshots table lists the original approval of pivekimab sunirine for adults with blastic plasmacytoid dendritic cell neoplasm. (FDA Drug Trials Snapshots)
Keep in mind: The table summarizes the original indication rather than a live prescribing record, so current official prescribing information is needed for conditions of use. (FDA Drug Trials Snapshots)
Japan · Public research agency (Japan AMED)
Stage at report: Conditional and time-limited Japanese approval (Japan AMED)
Intervention: RiHEART, iPS-cell-derived cardiomyocyte transplantation
Studied for / scope: Ischemic cardiomyopathy (Japan AMED)
AMED reports that Japan's MHLW approved the cardiomyocyte transplantation product for marketing with conditions and time limits on 6 March. (Japan AMED)
Keep in mind: This pathway requires further post-marketing evaluation and re-application for full approval; it is not an unrestricted approval in other countries. (Japan AMED)
Japan · Public research agency (Japan AMED)
Stage at report: Conditional and time-limited Japanese approval (Japan AMED)
Intervention: AMCHEPRY, iPS-cell-derived neural progenitor cell transplantation
Studied for / scope: Parkinson's disease (Japan AMED)
AMED reports that Japan's MHLW approved the neural progenitor cell transplantation product for marketing with conditions and time limits on 6 March. (Japan AMED)
Keep in mind: Additional efficacy and safety evaluation is required after marketing, with re-application for full approval within the designated period. (Japan AMED)
United States regulatory decision · Regulator (FDA Drug Trials Snapshots)
Stage at report: FDA-approved indication at original approval (FDA Drug Trials Snapshots)
Intervention: Icotyde (icotrokinra)
Studied for / scope: Moderate-to-severe plaque psoriasis in eligible people aged 12 and older (FDA Drug Trials Snapshots)
FDA lists the original approval for patients weighing at least 40 kg who are candidates for systemic therapy or phototherapy. (FDA Drug Trials Snapshots)
Keep in mind: An approval for this population is not a recommendation for every person with psoriasis, and the current prescribing information governs use. (FDA Drug Trials Snapshots)
United States regulatory decision · Regulator (FDA Drug Trials Snapshots)
Stage at report: FDA-approved indication at original approval (FDA Drug Trials Snapshots)
Intervention: Zycubo (copper histidinate)
Studied for / scope: Menkes disease (FDA Drug Trials Snapshots)
FDA's Drug Trials Snapshots table lists Zycubo's original approval to treat Menkes disease. (FDA Drug Trials Snapshots)
Keep in mind: The table is a summary of the original approval, and readers should consult current official prescribing information for the approved conditions of use. (FDA Drug Trials Snapshots)
