Global Drug ApprovalsMarch 2026
Global Drug Approvals
March 2026
22 drugs cleared by regulators across 6 regions. China led with 8 approvals, the FDA validated the first oral IL-23R cyclic peptide alongside two rare-disease gene therapies, and 104 drugs received expedited review designations signalling the next approval wave.
22 approvals across 6 regions in March 2026
March 2026’s approval volume reflects sustained regulatory momentum across all major markets. China’s NMPA breadth — spanning biosimilars, diagnostics, biologics, and vaccines — signals continued domestic pharma build-out. The FDA’s slate was the month’s most modality-diverse, led by icotrokinra, the first oral cyclic peptide approved for an immune receptor target, alongside two Accelerated Approvals for rare genetic diseases.
South Korea’s four approvals were dominated by fixed-dose combinations for metabolic disease, while Japan’s PMDA cleared a PI3Kα inhibitor for ovarian clear cell carcinoma — a histological subtype historically resistant to platinum chemotherapy. The EU approved estetrol for oestrogen deficiency, and India’s CDSCO cleared a semaglutide biosimilar, entering the growing GLP-1R agonist biosimilar competition.
All 22 approvals — March 2026
Click any row to explore the drug’s patent landscape and clinical data in Eureka Life Science.
| Drug | Target | Modality | Indication | Developer | Region |
|---|---|---|---|---|---|
| Icotrokinra | IL-23R | Cyclic peptide | Plaque psoriasis | Janssen Biotech | US (Mar 17) |
| Marnetegragene autotemcel | CD18 | Gene therapy | LAD-1 | Rocket Pharmaceuticals | US (Mar 26) |
| Tividenofusp alfa | IDS | Fc fusion protein | MPS II (Hunter syndrome) | Denali Therapeutics | US (Mar 24) |
| Relacorilant | GR | Small molecule | Platinum-resistant OC | Corcept Therapeutics | US (Mar 25) |
| Linerixibat | ISBT | Small molecule | Cholestatic pruritus (PBC) | GlaxoSmithKline | US (Mar 17) |
| Estetrol | ER | Small molecule | Oestrogen deficiency | Gedeon Richter | EU (Mar 26) |
| 99mTc-3PRGD2 | αvβ3 | Radionuclide diagnostic | Lung cancer imaging | Foshan Rui Diao | China (Mar 31) |
| Recombinant Human Hyaluronidase | Hyaluronic acid | Recombinant protein | Drug adjuvant | Shanghai Bao Pharma | China (Mar 31) |
| Recombinant Botulinum Toxin Type A | SNAP25 | Toxin | Glabellar frown lines | Claruvis | China (Mar 25) |
| Recombinant EPO stimulating protein | EPO receptor | Recombinant protein | Anaemia in CKD | Guangdong Sansheng | China (Mar 17) |
| Insulin Degludec biosimilar | INSR | Biosimilar | Type 2 diabetes | Zhuhai Federal Biomedical | China (Mar 3) |
| Higenamine Hydrochloride | β2-AR | Small molecule | Heart diseases | Zhuhai Rundu | China (Mar 31) |
| Adsorbed tetanus vaccine | — | Vaccine | Tetanus | Beijing Minhai | China (Mar 31) |
| Risovalisib | PI3Kα | Small molecule | Ovarian clear cell carcinoma | Haihe Biopharma | Japan (Mar 23) |
| Gadoquatrane | — | Contrast agent | CNS MRI imaging | Bayer Yakuhin | Japan (Mar 23) |
| Doravirine/Islatravir | RT (NNRTI+NRTTI) | Combination | HIV infections | MSD KK | Japan (Mar 6) |
| Metformin/Lobeglitazone/Empagliflozin | SGLT2; PPARγ | Triple combination | Type 2 diabetes | Chong Kun Dang | South Korea (Mar 10) |
| Chlortalidone/Telmisartan | NCC; AT1R | Combination | Essential hypertension | Yuhan Corp. | South Korea (Mar 5) |
| Acetaminophen combo (RP Bio) | Multiple | Combination | Common cold | RP Bio | South Korea (Mar 9) |
| Acetaminophen combo (COSMAX) | Multiple | Combination | Common cold | COSMAX PHARMA | South Korea (Mar 3) |
| Semaglutide biosimilar | GLP-1R | Biosimilar | Type 2 diabetes | NATCO Pharma | India (Mar 20) |
US highlights: icotrokinra and two rare-disease gene therapies
The FDA’s March approvals represented the month’s broadest modality range — oral peptides, gene therapies, an Fc fusion, and small molecules.
Icotrokinra — first oral IL-23R cyclic peptide
Janssen Biotech’s icotrokinra is a synthetic cyclic peptide targeting the IL-23 receptor — the first oral agent to reach this mechanism, distinguishing itself from injectable biologics that block IL-23 at the ligand level.
IL-23R · Cyclic peptide · First-in-classMarnetegragene autotemcel — Accelerated Approval gene therapy
Rocket Pharmaceuticals’ ex vivo gene therapy for Leukocyte Adhesion Deficiency Type 1 received Accelerated Approval, with post-marketing confirmatory trials required. Targets the CD18 gene defect.
CD18 · Gene therapy · Accelerated ApprovalTividenofusp alfa — BBB-crossing Fc fusion for MPS II
Denali Therapeutics’ IDS-targeted Fc fusion protein is engineered to cross the blood-brain barrier — addressing the neurological component of Hunter syndrome that standard enzyme replacement cannot reach.
IDS · Fc fusion · BBB-crossingRisovalisib — PI3Kα inhibitor for ovarian clear cell carcinoma
Haihe Biopharma’s risovalisib targets PI3Kα in ovarian clear cell carcinoma — a histological subtype historically resistant to platinum-based chemotherapy and lacking targeted therapy options.
PI3Kα · Small molecule · Oncology104 expedited review designations — signalling 2027–2028 approvals
Orphan Drug dominated at 55. The 10 Breakthrough Therapy designations span KRAS G12D, ADC modalities, rare metabolic disease, and haematology.
What March 2026 tells us about the next approval wave
Five durable trends visible in the March data that will shape the pipeline through 2027–2028.
Oral cyclic peptides enter immune receptor space
Icotrokinra’s approval validates oral cyclic peptides for targets previously served only by injectables. Expect this modality to pressure biologic share in psoriasis and extend to other IL-pathway indications within 2–3 years.
Two rare-disease gene therapies in a single month
LAD-1 and MPS II Accelerated Approvals in March signal continued FDA appetite for curative modalities in ultra-rare genetic disease. Both carry confirmatory trial requirements, but the precedent accelerates similar programs.
China’s biosimilar build-out accelerates
Insulin Degludec and EPO biosimilars in the same month reflect China’s broad-based domestic production push across chronic-disease indications. This trend compresses margins for originator biologics in the world’s largest pharma market.
KRAS & ADC BTDs signal next oncology cycle
GFH-375 (KRAS G12D) and YL-201 (ADC targeting CD276) Breakthrough Therapy designations confirm where the 2027–2028 oncology approval wave will concentrate. These are the programs to track now for competitive intelligence.
March 2026 drug approvals — key questions
22 drugs received regulatory approval in March 2026 across 6 regions: China (8), United States (5), South Korea (4), Japan (3), European Union (1), and India (1). The month was notable for modality diversity — gene therapies, radionuclide diagnostics, biosimilars, and the first oral IL-23R cyclic peptide all received clearance.
Icotrokinra (Janssen Biotech), a synthetic cyclic peptide targeting IL-23R, received FDA approval for plaque psoriasis on March 17, 2026. It is the first oral agent of its class targeting this receptor — distinguishing itself from existing injectable biologics that block IL-23 at the ligand level.
Venglustat (Sanofi), a UGCG (glucosylceramide synthase) inhibitor, received Breakthrough Therapy designation for Gaucher Disease Type 3 on March 18, 2026. It is a substrate reduction therapy that can cross the blood-brain barrier — addressing the neurological component of Type 3 that enzyme replacement therapy cannot reach.
104 drugs received expedited review pathway designations globally in March 2026: 55 Orphan Drug, 14 Priority Review, 11 Fast Track, 10 Breakthrough Therapy, 3 PRIME (EMA), 2 Accelerated Approval, 2 Conditional Marketing Approval, 2 Rare Pediatric Disease, 2 Regenerative Medicine Advanced Therapy, and 3 other designations.
China’s NMPA approved 8 drugs in March 2026 across five modality classes — small molecules, recombinant proteins, biosimilars, diagnostic radionuclides, and vaccines. This breadth reflects China’s sustained push to accelerate domestic pharma approvals across biosimilars, oncology diagnostics, and biologics for chronic-disease indications.
The 10 Breakthrough Therapy designations in March 2026 — including GFH-375 (KRAS G12D, pancreatic cancer), YL-201 (ADC, small cell lung cancer), Venglustat (UGCG, Gaucher Type 3), and HSK-31679 (THR-β, MASH) — signal where the next cycle of approvals will concentrate through 2027–2028, particularly in KRAS-targeted oncology, ADC modalities, lysosomal storage disorders, and metabolic liver disease.
Data and insights on this page are based on a limited drug approval, patent, and biopharma intelligence dataset and are for reference only. For comprehensive analysis visit PatSnap Eureka Life Science.
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