The new year is in full swing. In the U.S., the oral solid dose sector has already put up some regulatory wins and has a handful of key decisions waiting in the wings.
The industry’s most established and most favored dosage forms are coming off a strong 2024. Last year, the Center for Drug Evaluation and Research (CDER) approved a total of 50 new drugs, 40% of which were OSD formulations — 14 tablets and six capsules. Of the new approvals in 2024, CDER identified five tablets and four capsules as ‘first-in-class’ — drugs that produce a novel pharmacologic effect in a disease.
How will 2025 compare? Here’s a closer look at the OSD approvals already making waves — and the decisions still on the horizon.
Recent Approvals
CDER has approved six novel drugs so far in 2025, four of which are oral solid dose formulations. Of the new OSD approvals, two are tablets, one is a capsule and one approval comes in both capsule and tablet form.
Vertex’s Journavx
Approval Date: January 30, 2025
The approval of Vertex’s Journavx, an oral, non-opioid pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain, marks the first new class of pain medicine approved in the U.S. in more than 20 years.
The twice-daily oral tablets reduce pain by targeting NaV1.8, a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. Importantly, because Journavx blocks pain signals only found in the periphery, not in the brain, it provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.
SpringWorks Therapeutics’ Gomekli
Approval Date: February 11, 2025
SpringWorks’ MEK inhibitor, Gomekli, was approved for the treatment of both adults and children with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas — tumors that grow along the peripheral nerve sheath and can cause severe disfigurement, pain and functional impairment — that can’t be removed through surgery.
Gomekli, available in both capsule form and as a tablet for oral suspension, is the first and only medicine approved for both adults and children with NF1, a rare genetic disorder caused by a mutation in the NF1 gene. With the approval, SpringWorks was granted a rare pediatric disease priority review voucher by the FDA.
Ono Pharmaceutical’s Romvimza
Approval Date: February 14, 2025
Ono Pharmaceutical’s kinase inhibitor, Romvimza, was approved for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection could potentially cause worsening functional limitation or severe morbidity.
Surgery is the main treatment option for TGCT, a rare, non-malignant tumor that forms within or near joints. But for the subset of patients whose condition is made worse by surgical removal, systemic treatment options are limited. Romvimza oral capsules — developed by Ono’s subsidiary, Deciphera Pharmaceuticals — provide a new therapeutic option. The drugs will compete with Daiichi Sankyo’s TGCT capsules, branded Turalio, which won FDA approval in 2019.
Mirum Pharmaceuticals’ Ctexli
Approval Date: February 24, 2025
Mirum’s Ctexli tablets are the first and only treatment approved for adults with cerebrotendinous xanthomatosis (CTX), a rare and debilitating disease resulting from a deficiency of a key enzyme in the bile acid synthesis pathway.
CTX is characterized by fatty yellow nodules located in the connective tissues within the brain. As the clinical course progresses, irreversible neurological deterioration leads to premature death. Mirum’s tablets are made of chenodiol, also known as chenodeoxycholic acid, a naturally occurring bile acid that was originally approved decades ago for the treatment of radiolucent stones in the gallbladder.
The approval came in advance of Ctexli’s Prescription Drug User Fee Act (PDUFA) date, which was March 28.
Approvals to Watch
With numerous PDUFA dates already on the books, the FDA is weighing decisions that could shape treatment options across multiple therapeutic areas, including the first antibiotic in a novel class of treatments for UTIs in over 20 years and the first non-injectable, on-demand treatment for HAE attacks.
Elevar Therapeutics’ rivoceranib
PDUFA Date: March 20, 2025*
After initially issuing a complete response letter, the FDA accepted Elevar’s new drug application resubmission this past October for the first-line use of the oral VEGF TKI, rivoceranib, in combination with the PD-1 inhibitor, camrelizumab, for patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common type of liver cancer.
The resubmission included the final analysis of the phase 3 CARES-310 study presented during the 2024 American Society of Clinical Oncology Annual Meeting, which reported median overall survival (mOS) of 23.8 months — the longest mOS for any treatment in a global phase 3 trial for patients with uHCC.
Elevar believes that, if approved, rivoceranib plus camrelizumab has the potential to change the clinical practice in the first-line setting for patients with advanced liver cancer.
*On March 17, 2025, Yang Gon Jin, chairman of the board at HLB, Korean parent company to U.S.-based Elevar, appeared on the company's official YouTube channel to share that Elevar and Jiangsu Hengrui had received a second CRL from the U.S. FDA.
GSK’s gepotidacin
PDUFA Date: March 26, 2025*
GSK revealed last October that the FDA had accepted its new drug application for gepotidacin, a first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults and adolescents with uncomplicated urinary tract infections (uUTIs). If approved, gepotidacin capsules will be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years.
New treatments are needed as the number of infections caused by drug-resistant bacteria are increasing, driving up treatment failure rates. Gepotidacin, the result of a 2013 public-private partnership between GSK and the Biomedical Advanced Research and Development Authority (BARDA), is a triazaacenaphthylene antibiotic that inhibits bacterial DNA replication.
Last year, GSK shared positive phase 3 data for the antibiotic in gonorrhea as well, teeing up another possible FDA submission. In the 600-patient gonorrhea trial, gepotidacin demonstrated non-inferiority, with a 92.6% success rate compared to a 91.2% success rate for intramuscular ceftriaxone plus oral azithromycin.
*On March 25, 2025, the FDA approved GSK’s gepotidacin, branded Blujepa, for the treatment of uncomplicated urinary tract infections.
KalVista Pharmaceuticals’ sebetralstat
PDUFA Date: June 17, 2025
KalVista’s sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks — painful and debilitating tissue swelling in various locations of the body.
If approved, sebetralstat will be the first oral, on-demand treatment for HAE in patients aged 12 years and older. In the company’s phase 3 KONFIDENT trial, the largest clinical trial ever conducted in HAE, the median time to beginning of symptom relief was 1.61 hours with sebetralstat 300 mg tablets and 1.79 hours with sebetralstat 600 mg tablets.
KalVista plans to transition ongoing participants in the trial to an oral disintegrating tablet formulation to support a planned 2026 sNDA filing of the additional formulation.
*On June 13, 2025 the FDA notified the KalVista that the previously disclosed June 17 PDUFA goal date will not be met due to “heavy workload and limited resources.”
Bayer’s elinzanetant
PDUFA Date: July 26, 2025
Bayer’s elinzanetant is an investigational once-daily, non-hormonal treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause.
The drug is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of VMS, also known as hot flashes, administered orally. Elinzanetant is thought to address VMS by modulating a group of estrogen sensitive neurons, called KNDy neurons, in the hypothalamus region of the brain.
Bayer shared three positive phase 3 trial readouts for elinzanetant in 2024. The drugmaker has also tested the efficacy and safety of elinzanetant in women with VMS caused by endocrine therapy for treatment or prevention of breast cancer.
Chimerix’s dordaviprone
PDUFA Date: August 18, 2025
Chimerix’s lead clinical asset, dordaviprone, is a novel first-in-class treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults.
If approved, the oral small molecule would the first FDA-approved therapies specifically for the condition; current standard of care is radiation. The agency has granted dordaviprone priority review and it is eligible for a rare pediatric disease priority review voucher.
Jazz Pharmaceuticals recently announced that it will acquire Chimerix for $935 million, picking up the dordaviprone asset in the deal.