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Oral Medicine

Treatments and trials using Oral Medicine, with the same country and access zoom as New Developments.

All New Developments

Oral Medicine breakthroughs

FDA ApprovedUnited States

New Pill Option for Kidney Disease in Adults With Type 1 Diabetes

Kerendia (finerenone) — once-daily oral pill to lower urine protein in adults with kidney disease and type 1 diabetes

FDA supplemental approval announced 17 September 2026 for a new use of Kerendia (finerenone) tablets — a once-daily oral non-steroidal…

This is for adults with type 1 diabetes who already have chronic kidney disease with protein in the urine and…

FDA ApprovedUnited States

First FDA-Approved Pill for Children 4–11 With APDS

Joenja (leniolisib) — first labelled oral treatment for children 4–11 with APDS who weigh at least 27 kg

FDA supplemental approval on 11 September 2026 for Joenja (leniolisib) tablets — expanding the labelled APDS door to adult and pediatric patients 4…

This is for caregivers of children 4–11 years with genetically confirmed APDS who weigh at least 27…

Health Canada/FDA ApprovedUnited StatesCanadaJapanEuropean Union

New Pill for Hormone-Positive Advanced Breast Cancer

Etcamah (camizestrant) — oral ER antagonist with CDK4/6 for ESR1m HR+/HER2− advanced breast cancer

FDA accelerated approval on 4 September 2026 for Etcamah (camizestrant) tablets — an oral estrogen receptor antagonist — in combination with…

This is for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who are…

FDA ApprovedUnited States

New Pill for Ovarian Cancer That No Longer Responds to Chemo

Lifyorli (relacorilant) — oral GR antagonist with nab-paclitaxel for platinum-resistant ovarian cancer

FDA traditional (full) approval on 25 March 2026 for Lifyorli (relacorilant) capsules — an oral glucocorticoid receptor (GR) antagonist — in…

This is for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer…

FDA ApprovedUnited StatesChina

New Pill for Mantle Cell Lymphoma After Prior Treatment

Beqalzi (sonrotoclax) — oral BCL-2 inhibitor for R/R mantle cell lymphoma after ≥2 lines including a BTK inhibitor

FDA accelerated approval on 13 May 2026 for Beqalzi (sonrotoclax) tablets — an oral BCL-2 inhibitor — for adults with relapsed or refractory…

This is for adults with relapsed or refractory mantle cell lymphoma who have already had at least two…

FDA ApprovedUnited States

New Oral Treatment for Multiple Myeloma After Prior Therapy

Zenbexus (iberdomide) — first labelled CELMoD for adults with multiple myeloma after ≥1 prior line

FDA accelerated approval on 13 August 2026 for Zenbexus (iberdomide) capsules — an oral cereblon-modulating protein degrader (CELMoD) — in…

This is for adults with multiple myeloma who have already had at least one prior treatment that included a…

FDA ApprovedUnited States

New Pill for a Rare Gene-Related Lung Cancer

Jideytro (zidesamtinib) — oral ROS1 kinase inhibitor after a prior ROS1 TKI

On 22 July 2026 the FDA labelled Jideytro (zidesamtinib) tablets for adults with locally advanced or metastatic ROS1-positive NSCLC who…

Jideytro is a US-labelled oral pill for adults whose ROS1-positive lung cancer has already been treated with…

FDA ApprovedUnited StatesJapan

New Oral Medicine to Help Prevent COVID-19 After Exposure

Xocova / Zokovea (ensitrelvir) — oral COVID-19 post-exposure prophylaxis

The first FDA-labelled oral option for COVID-19 post-exposure prophylaxis (PEP). On 29 May 2026 the FDA approved Xocova (ensitrelvir) tablets…

The first FDA-labelled oral option for COVID-19 post-exposure prophylaxis (PEP). On 29 May 2026…

FDA ApprovedUnited States

New Oral Antibiotic for Complicated Urinary Tract Infections

Utebzi (tebipenem pivoxil) — first oral carbapenem for adults with complicated UTI

The first FDA-approved oral carbapenem for adults. On 17 June 2026 the FDA labelled Utebzi (tebipenem pivoxil) tablets for complicated urinary…

The first FDA-approved oral carbapenem for adults. On 17 June 2026 the FDA labelled Utebzi…

FDA ApprovedUnited States

New Daily Pill for Advanced Breast Cancer After Hormone Therapy

Veppanu (vepdegestrant) — first FDA-approved PROTAC for ESR1-mutated ER+/HER2− advanced breast cancer

The FDA labelled a once-daily 200 mg oral PROTAC estrogen-receptor degrader tablet — take with food, swallow whole — for adults with ER-positive,…

The FDA labelled a once-daily 200 mg oral PROTAC estrogen-receptor degrader tablet — take with food,…

FDA ApprovedUnited States

New Pill for Hard-to-Control High Blood Pressure

Baxfendy (baxdrostat) — first aldosterone-synthase inhibitor for adults whose blood pressure is not adequately controlled

The FDA labelled a once-daily 1 mg or 2 mg oral aldosterone synthase inhibitor tablet — take with or without food, swallow whole — in combination with…

The FDA labelled a once-daily 1 mg or 2 mg oral aldosterone synthase inhibitor tablet — take with or…

FDA ApprovedUnited States

New Daily Pill for Moderate-to-Severe Psoriasis (Ages 12+)

Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis — 12 and older, at least 40 kg

The FDA labelled a once-daily 200 mg oral IL-23 receptor peptide for moderate-to-severe plaque psoriasis in people 12 and older who weigh at least 40 kg and…

The FDA labelled a once-daily 200 mg oral IL-23 receptor peptide for moderate-to-severe plaque psoriasis in…

New Pill for Chronic Hives Not Controlled by Antihistamines

Rhapsido (remibrutinib) for adult chronic spontaneous urticaria still active on H1 antihistamines

The FDA, Health Canada, the European Commission, and the UK MHRA have labelled an oral BTK inhibitor — 25 mg twice daily — for adults with chronic spontaneous…

The FDA, Health Canada, the European Commission, and the UK MHRA have labelled an oral BTK inhibitor — 25 mg…

FDA ApprovedUnited States

New Daily Pill to Lower High ("Bad") Cholesterol

Lipfendra (enlicitide) — first oral PCSK9 inhibitor for high LDL-C in adults

The FDA labelled a once-daily 20 mg oral PCSK9 inhibitor tablet — take in the morning on an empty stomach — as an adjunct to diet and exercise to lower…

The FDA labelled a once-daily 20 mg oral PCSK9 inhibitor tablet — take in the morning on an empty…

New Oral Medicine for Narcolepsy Type 1 in Adults

Orzeyful (oveporexton) for narcolepsy type 1

The FDA labelled oveporexton for adults with narcolepsy type 1 on 5 August 2026 — and said it will be lawful to market only after DEA scheduling. Japan’s PMDA…

The FDA labelled oveporexton for adults with narcolepsy type 1 on 5 August 2026 — and said it will be lawful…

New Daily Pill for Chronic Weight Management in Adults

Foundayo (orforglipron) for chronic weight management

FDA labelled oral orforglipron for chronic weight management in adults. UK MHRA also labelled weight management and type 2 diabetes — those lines stay…

FDA labelled oral orforglipron for chronic weight management in adults. UK MHRA also labelled weight…

New Daily Pill for Adult Muscle and Skin Inflammation

Lisraya (brepocitinib) — first oral TYK2/JAK1 tablet labelled for adult dermatomyositis

FDA labelled a once-daily 30 mg pill for dermatomyositis in adults (27 August 2026), with a boxed JAK-class…

New Pill for Itch from a Bile-Duct Disease

Lynavoy (linerixibat) for cholestatic itch in adults with primary biliary cholangitis — oral IBAT inhibitor

The FDA (17 Mar 2026) and UK MHRA (1 May 2026) labelled an oral 40 mg tablet twice daily for cholestatic pruritus associated with primary biliary…

The FDA (17 Mar 2026) and UK MHRA (1 May 2026) labelled an oral 40 mg tablet twice daily for cholestatic…

Health Canada/FDA ApprovedUnited StatesCanada

New Pill for a Gene-Related Advanced Lung Cancer

Hyrnuo (sevabertinib) for HER2 TKD-mutant NSCLC

The FDA and Health Canada have labelled an oral HER2 tyrosine-kinase inhibitor for adults with locally advanced or metastatic NSCLC whose tumours have HER2…

The FDA and Health Canada have labelled an oral HER2 tyrosine-kinase inhibitor for adults with locally…

New Pill for Advanced Pancreatic Cancer

Rasonque (daraxonrasib): the first RAS(ON) pill for metastatic pancreatic adenocarcinoma

The FDA approved this RAS(ON) pill on 26 August 2026 for metastatic pancreatic adenocarcinoma. It is not a Canadian pharmacy drug. SAP, a first-line trial…

The FDA approved this RAS(ON) pill on 26 August 2026 for metastatic pancreatic adenocarcinoma. It is not a…

New Pill for Scarred-Lung Disease in Adults

Jascayd (nerandomilast) for IPF and PPF

The FDA, Europe, and the UK have labelled nerandomilast for adults with idiopathic pulmonary fibrosis and for adults with progressive pulmonary fibrosis.…

The FDA, Europe, and the UK have labelled nerandomilast for adults with idiopathic pulmonary fibrosis and for…

New Pill When the Heart Muscle Is Too Thick

Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy

The FDA, Europe, the UK, and China have labelled aficamten for symptomatic obstructive HCM in adults. England's NHS has a 30-day funding clock from NICE.…

The FDA, Europe, the UK, and China have labelled aficamten for symptomatic obstructive HCM in adults.…