With seven months of 2026 behind us, here’s a look at the regulatory wins shaping the U.S. oral solid dose sector.
Last year, the Center for Drug Evaluation and Research (CDER) approved a total of 46 new drugs, 43% of which were OSD formulations — 14 tablets, four capsules, one tablet/capsule co-pack, and one approval in both capsule and tablet form.
How is 2026 shaping up? CDER has approved 30 novel drugs so far, half of which are oral solid dose formulations. Of the new OSD approvals, 13 are tablets and two are capsules. Here’s a closer look at the 2026 OSD approvals:
Takeda’s Orzeyful tablets
Approval Date: August 5, 2026
Takeda’s Orzeyful is the first FDA-approved medication to treat narcolepsy type 1 (NT1) by targeting the cause of the disease.
Orzeyful is an oral orexin receptor 2 (OX2R) agonist. By stimulating OX2R, it treats orexin deficiency, therefore increasing wakefulness and reducing abnormal REM phenomena. This provides a holistic therapy rather than treating individual symptoms.
Otsuka’s Simtriyo capsules
Approval Date: July 24, 2026
Otsuka Pharmaceutical’s Simtriyo is the first norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) to treat ADHD. This new approach to treatment increases the availability of the neurotransmitters for pathways involved in attention and behavioral regulation. The drug will hit the market later this year after scheduling by the DEA.
GSK’s Jideytro tablets
Approval Date: July 22, 2026
GSK’s Jideytro is a ROS1 selective inhibitor approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor. It marks GSK's first approval in lung cancer.
Merck & Co’s Lipfendra tablets
Approval Date: July 15, 2026
Merck’s Lipfendra is a novel macrocyclic peptide that inhibits PCSK9 with LDL receptors by binding to PCSK9. It is the first PCSK9 inhibitor to receive FDA approval to treat hypercholesterolemia.
GSK & Spero’s Utebzi tablet
Approval Date: June 17, 2026
Utebzi’s approval for complicated urinary tract infections, including pyelonephritis, in adults, marks the first oral carbapenem antibiotic cleared in the U.S.
The drug was originally developed by Meiji Seika Pharma in Japan, where it has been available as an oral pediatric antibiotic since 2009. Spero licensed the compound and conducted the U.S. clinical program; GSK subsequently acquired the global rights from Spero.
Shionogi’s Xocova tablets
Approval Date: May 29, 2026
Xocova is a SARS-CoV-2 main protease inhibitor that acts as a post-exposure prophylaxis for adults and pediatric patients aged 12 and above. It is the first oral antiviral to prevent symptomatic COVID-19 after contact with an infected individual.
AstraZeneca’s Baxfendy tablets
Approval Date: May 15, 2026
AstraZeneca’s Baxfendy is a first-in-class, highly-selective, potent aldosterone synthase inhibitor (ASI) that inhibits the production of aldosterone, preventing high blood pressure at the same time as lowering the risk for heart and kidney problems. It is approved for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adults who are not adequately controlled on other agents.
BeOne’s Beqalzi tablets
Approval Date: May 13, 2026
BeOne Medicines’ Beqalzi is the first approved BCL2 inhibitor to treat relapsed or refractory mantle cell lymphoma. It’s available to adults who have received at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
The drug, which is designed to be more potent, selective, and convenient with greater efficacy and tolerability, received accelerated approval.
Arvinas’ Veppanu tablets
Approval Date: May 1, 2026
Veppanu tablets are a heterobifunctional protein degrader indicated for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer. The drug is the first proteolysis targeting chimera (PROTAC) to receive approval from the FDA.
After discovery by Arvinas, Veppanu was developed jointly by Arvinas and Pfizer. The companies partnered with Rigel Pharmaceuticals to maximize the commercial potential of the drug.
Merck’s Idvynso tablets
Approval Date: April 20, 2026
Merck’s Idynso is a two-drug regimen — doravirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor and islatravir, a nucleoside analog reverse transcriptase inhibitor — administered in a once-daily pill to treat HIV-1 infection in adults. The drug is for adults with virologically-suppressed HIV-1 with no history of virologic treatment failure.
Eli Lilly’s Foundayo tablets
Approval Date: April 1, 2026
Foundayo is a small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist approved for adults with obesity or overweight with a weight-related medical condition. Lilly licensed the drug — which is now the first oral GLP-1 for weight loss that has no food or water restrictions — from Chugai Pharmaceutical in 2018.
Corcept’s Lifyorli capsules
Approval Date: March 25, 2026
Corcept Therapeutics’ Lifyorli capsules are a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel (chemotherapy) for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
By inhibiting cortisol activity in cancer and immune cells, Lifyorli makes chemotherapy more effective and may indirectly activate patients’ immune systems.
Janssen’s Icotyde tablets
Approval Date: March 17, 2026
Janssen Biotech’s Icotyde is the first oral interleukin-23 (IL-23) receptor antagonist to treat moderate to severe psoriasis. The once-daily pill originates from a deal between J&J and Protagonist Therapeutics inked in 2017.
GSK’s Lynavoy tablets
Approval Date: March 17, 2026
GSK’s Lynavoy, an ileal bile acid transporter (IBAT) inhibitor, is the first and only medication specifically approved to treat severe, debilitating internal itching — known as cholestatic pruritus — in adults with the rare liver disease primary biliary cholangitis.
Vanda’s Bysanti tablets
Approval Date: February 20, 2026
Vanda Pharmaceuticals' Bysanti is an atypical antipsychotic approved to treat manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults. The new chemical entity was shown to be bioequivalent to Fanapt (iloperidone) in clinical studies, meaning it has a proven safety profile for treating serious psychiatric conditions.