The Atlas

32 topics

Metabolic health

GLP-1s & metabolic therapies

Oral VK2735’s SUNRISE program is announced, while registry recruitment remains pending with November starts; maintenance wording is corrected to daily oral dosing. Zenagamtide switching now records an actual start. A monthly-or-less-frequent Pfizer GLP-1 protocol adds early safety research.

Next: Late 2026 · Sponsor forecast

Cardiovascular prevention

AMBIENCE and plaque-guided prevention studies ask clinical-event and clinical-utility questions. ARO-DIMERPA’s primary-completion estimate moves to July 2027; its early safety and lipid measurements remain separate from cardiovascular benefit.

Next: October 2026 · Registry estimate; not yet recruiting

Kidney health

FDA accepts the finerenone application for CKD without diabetes, without a disclosed decision date; this is not approval. PYC-003 adds early ADPKD target engagement, not demonstrated kidney-function preservation.

Next: Q4 2026 · Sponsor forecast

Liver health

A new placebo-controlled Kylo-0603 trial will measure MRI liver-fat reduction. Earlier senolytic biopsy signals and larger FGF21/THRβ programs remain distinct from proven reductions in liver complications; complete patient results and harms remain pending.

Next: Q4 2026 · Sponsor forecast

Longevity & healthspan

A newly disclosed 31-person ELITE combination pilot measures eight-week function and digital signals, with no posted results or lifespan claim. Larger healthspan evidence remains unsettled; the alleged PEARL 24-month follow-up remains unconfirmed.

Next: October 16, 2026 · Registry estimate

Screening & cancer

Cancer treatment & vaccines

FDA’s October 8 action adds atezolizumab with chemotherapy after resection of stage III dMMR colon cancer, supported by ATOMIC disease-free survival and substantial treatment toxicity. Formulation-specific ages and weight limits differ; overall-survival benefit is not established. New NEONIPIGA follow-up is small, uncontrolled and distinct from randomized recurrence-prevention evidence.

Next: October 24, 2026 · Scheduled ESMO presentation

Cancer blood tests & screening

SOARA plans to track ovarian blood-screening harms and invasive workups; a separate urine lung-test study validates existing nodules in never-smokers. These registrations add modalities without proving mortality benefit. Galleri's prior primary-endpoint miss and nonbinding FDA vote remain separate.

Next: October 25, 2026 · Scheduled ESMO poster

Genetic screening & risk

A small matched study associates genotype-guided chemotherapy dosing with fewer severe toxicities. MLD newborn screening connects diagnosis to early care in a small follow-up cohort; MECP2 findings emphasize penetrance and counseling uncertainty. Broad PRS and embryo-selection outcomes remain unproven.

Next: Summer 2027 · Government forecast

Whole-body MRI

A new review of heterogeneous screening cohorts estimates pathology-confirmed cancer yield but cannot establish improved patient outcomes. Downstream workups, false positives, overdiagnosis and the benefit of repeated screening remain unresolved.

Update timing not established

Brain & mental health

Mental-health treatments

the UK MHRA has strengthened antidepressant patient safety communication, including more prominent suicidal-thought/behavior warnings and explicit PSSD terminology for selected leaflets. This concerns known risks and communication, without a new reliable frequency estimate or a new U.S. label change. The separate supporting leaflet is expected in 2027. Existing antidepressant and broader mental-health programs remain diagnosis-specific; the prior PEACE pilot, BALANSYA formulation and WELTRUZA indication must retain their distinct evidence and geography.

Next: October 2026 · Registry estimate; not yet recruiting

Psilocybin & related therapies

FDA seeks input on ibogaine trial safeguards through November 20. IBO-CARE proposes an opioid-use-disorder comparison but explicitly awaits funding and authorization; its IND is not filed. Psychedelic efficacy, supervised safety and non-psychedelic treatments remain distinct.

Next: Q4 2026 · Sponsor forecasts

Alzheimer’s

Banner has announced the first randomization in API-2, testing donanemab, nivagacetor and their combination in the Colombian PSEN1 E280A kindred. The registered primary endpoints concern amyloid removal/maintenance, so this is no demonstration of dementia prevention. It joins a broader pipeline in which biomarker and diagnostic-management findings must remain distinct from cognitive/function outcomes. The prior PLASMAR disclosure study did not test treatment efficacy, and presymptomatic combinations remain investigational.

Next: Around year-end 2026 / early 2027 · Sponsor forecast

Hearing & vision

BRUNELLO adds year-one vision noninferiority with more proliferative-retinopathy events and adverse-event discontinuations. MCO-010 reports four-year inherited-RP gains, with follow-up denominators and intervals missing; this does not establish acquired-AMD benefit.

Next: Q4 2026 · Sponsor forecast

Sleep

Insomnia

eNightfall adds a randomized test of stepped digital CBT-I with remission and 12-month follow-up in cancer survivors. Existing onset/maintenance drug indications, clinical insomnia outcomes and laboratory sleep-architecture measurements remain separate.

Next: November 2027 · Registry estimate

Obstructive sleep apnea

AD109 will present symptom, postmenopausal and hypoxic-burden analyses at CHEST on October 20. Other formal programs include IHL-42X, monthly berobenatide and tirzepatide-versus-PAP; trial plans do not show that drugs replace PAP.

Next: October 20, 2026 · Scheduled conference presentation

Narcolepsy & excessive sleepiness

Orexin agonists and established wake-promoting treatments remain diagnosis-specific. A newly public 20-person ofatumumab NT1 protocol explores an immune approach without a comparator; one-month symptoms and one-week safety cannot establish durable benefit.

Next: By November 2026 · Conditional sponsor forecast

Circadian rhythm disorders

Recovered September 29 sponsor data report a 37.1-minute earlier sleep onset versus placebo with tasimelteon in delayed-phase disorder. The small 28-day analysis lacks confidence intervals and detailed harms; registry results and any new indication remain pending.

Next: December 2026 · Registry estimate

Restless legs syndrome

Newly recovered IV-iron and extended-duration TOMAC programs target refractory RLS and awakenings. An uncontrolled venous-ablation association does not establish a general RLS cure or causal benefit.

Next: October 2026 · Registry estimate

Function & immunity

Bones, joints & cartilage

AGILI-C adds a European commercial launch for selected cartilage defects; its five-year randomized paper is April evidence, not a new October result. Bone-density studies remain separate from fracture prevention, and structural cartilage repair remains separate from pain, function and avoided joint replacement.

Next: Late 2026 · Sponsor forecast

Muscle preservation

COURAGE’s one-year trevogrumab body-composition results remain distinct from strength or fewer falls. A new placebo-controlled forazapadin trial in inherited FSHD will measure muscle force; it has not begun recruiting and does not establish muscle preservation during weight loss.

Next: Late 2026 · Sponsor forecast

Non-opioid pain

SL1002 completes pivotal knee-OA pain enrollment, with Q2 2027 results forecast. Suzetrigine adds a randomized knee-replacement opioid-sparing trial and closes its uncontrolled diabetic-neuropathy extension enrollment; chronic-pain approval and comparative benefit remain unproven.

Next: By end-2026 · Sponsor forecast

Autoimmune therapies

Immune-reset research includes a newly registered in-vivo CD19 CAR-T study, without confirmed dosing or results. Two distinct Chinese CAR-T protocols are withdrawn with zero participants. A completed rap-cel lupus record does not establish lifting of the wider autoimmune-program hold; remission, durable benefit and safety remain separate questions.

Next: Q4 2026 · Sponsor forecast

Allergy & airway disease

New COPD registry tables add detailed efficacy and harms to older AERIFY-1 and ALIENTO results; companion pivotal trials were negative, and itepekimab remains discontinued. Ensifentrine’s ENHANCE-3 registers a larger exacerbation study, separate from its existing U.S. maintenance approval. Food allergy, asthma and sinus programs retain distinct indications and endpoints.

Next: H2 2026 · Conditional sponsor forecast

Infections, vaccines & antibiotics

A large randomized shingles-vaccine trial will directly measure cardiovascular events. Travelan’s new full challenge-study report retains a nonsignificant diarrhea endpoint and wide uncertainty; newer antibiotics, phages and transplant-vaccine programs remain distinct.

Next: By end-2026 · Sponsor forecast

Aesthetics & Dental

Skin aging & laxity

A new décolletage-wrinkle publication reports a randomized SB-NASHA benefit at 12 weeks, with common injection-site reactions. The safety population is broader than the randomized efficacy cohort. Wrinkle response remains distinct from generalized skin regeneration, durable lifting or volume restoration.

Next: October 15–17, 2026 · Announced congress presentation; exact day unspecified

Acne & rosacea

The matched U.S. AURORA denifanstat protocol is now public and recruiting, moving beyond the earlier unmatched trial plan; actual first dosing remains unverified.

Next: October 2026 · Sponsor forecast

Pigmentation & skin tone

Newly posted toner-adjunct results show no clear descriptive advantage alongside hydroquinone and sunscreen. The formulation and comparative statistics are missing; vitiligo programs retain their separate development status.

Next: H2 2026 · Sponsor forecast

Scars & stretch marks

New comparative scar reports retain substantial attrition and a nonsignificant total-score comparison. Neither demonstrates reliable eradication of established scars, durable functional improvement or stretch-mark efficacy.

Next: October 2026 · Registry estimate; not yet recruiting

Hair loss & graying

Adult BRAVE-AA follow-up adds four-year response maintenance among selected prior responders and safety follow-up up to five years. For pattern hair loss, PP405 now has sponsor-confirmed first dosing in Phase 2/3 AWAKEN and a separate women's Phase 2 study forecast by end-2026; RLS-1496 remains a planned program without verified patient efficacy. Alopecia areata and pattern hair loss remain separate.

Next: End of 2026 · Sponsor forecast announced October 14, 2026

Facial volume & contour

Recovered U.S. Belotero launch dates are sponsor forecasts: October 14 for Volume and December 1 for Intense. Earlier indication-specific approvals remain distinct from actual local inventory and comparative cosmetic benefit.

Next: December 1, 2026 · Sponsor forecast

Fat removal & cellulite

SCULPT registers a ten-person within-patient topical thigh study using circumference as its primary endpoint. It does not establish local fat-volume reduction or cellulite smoothing; CBL-514, other injectable programs and visceral-fat evidence retain their own development and safety limits.

Next: By end-2026 · Sponsor forecast

Dental alignment & regeneration

A new P11-4 protocol tests repeated versus single application for early enamel lesions. The primary endpoint and completion timing differ between the paper and registry; no clinical results are yet reported.

Next: October 31, 2027 · Registry estimate; protocol discrepancy