Drug approvals are the number everyone quotes. FDA's drug center approved 46 novel drugs in 2025, 50 in 2024 and 55 in 2023, close to its ten-year average of about 47. By that measure, not much has changed.

The pipeline underneath has changed a great deal. We counted new interventional trials by treatment type in the ClinicalTrials.gov registry, and the types do not move together.

Which modalities are growing?

1. 12021: mRNA trial starts peak

Bispecific antibodyCAR-TGLP-1 agonistAntibody-drug conjugatemRNARNAi / antisense

Source: ClinicalTrials.gov API v2, queried October 4, 2026. Intervention-field term search, restricted to drug, biological, genetic or combination-product interventions. A trial can count under more than one type.

View data

year	bispecific	car	glp	adc	mrna	rnai
2015	11	43	71	20	8	14
2016	15	78	105	25	12	12
2017	21	105	78	16	9	19
2018	34	109	71	37	11	12
2019	48	145	107	21	14	19
2020	43	162	63	41	23	11
2021	80	191	93	46	129	32
2022	78	198	95	51	119	19
2023	91	220	115	65	88	26
2024	93	335	169	85	69	42
2025	173	372	193	95	82	30

Four types show sustained growth.

• Bispecific antibodies went from 11 new trials in 2015 to 173 in 2025, and 2025 alone nearly doubled 2024 (93).
• CAR-T rose from 43 to 372, almost a 9-fold increase, with the sharpest climb in 2024 and 2025.
• Antibody-drug conjugates rose from 20 to 95.
• GLP-1 drugs rose from 71 to 193, with most of the increase after 2022.

Two types do not follow the trend. RNAi and antisense trials hover between 11 and 42 a year with no clear direction. mRNA went from 8 in 2015 to 129 in 2021, when COVID-19 vaccines pushed it up, then fell to 119, 88, 69 and 82. The 2025 figure is 36% below the peak.

Does the approval count reflect any of this?

Not yet, and that is expected. Trials take years to turn into approvals.

Source: FDA, New Drug Therapy Approvals 2024 (2015 to 2024); RAPS (2025). Counts novel drugs approved by CDER only. Vaccines and cell and gene therapies are regulated by a different center and are not included.

View data

year	approvals
2015	45
2016	22
2017	46
2018	59
2019	48
2020	53
2021	50
2022	37
2023	55
2024	50
2025	46

The approval count has stayed in a band of roughly 37 to 59 for a decade, apart from 22 in 2016. Whatever is shifting in the pipeline has not changed the total. Cell therapies such as CAR-T are also regulated by FDA's biologics center, not the drug center that produced this count, so a growing share of the new modalities would not show up in this chart at all.

What this does and does not show

The trial counts measure activity, not success. A registered trial can fail, be withdrawn or never enroll. Our searches look for terms in the intervention fields, so they will miss trials that use other names and may count some trials that merely compare against a drug of that type. Late registration means the most recent years may rise as records are added. The GLP-1 search covers six drug names and class terms, and the other searches cover fewer, so the numbers should be compared by trend, not by size.

Sources

1. ClinicalTrials.gov, Data API. Interventional studies by start year, with the intervention-field queries listed under the chart, retrieved October 4, 2026. Queries: mRNA; siRNA OR RNAi OR "antisense oligonucleotide" OR "small interfering RNA"; "CAR-T" OR "chimeric antigen receptor"; "antibody-drug conjugate" OR "antibody drug conjugate"; bispecific; semaglutide OR tirzepatide OR liraglutide OR "GLP-1" OR dulaglutide.
2. US FDA, Advancing Health Through Innovation: New Drug Therapy Approvals 2024: CDER novel approvals 2015 to 2024.
3. RAPS, CDER approved 46 novel drugs in 2025.