In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) hit a significant milestone, approving 55 new drugs, an increase of nearly 50% from last year and second only to the all-time high of 2018 . This number highlights the innovative trend in the pharmaceutical field and demonstrates the industry’s great success in different treatment areas. What is particularly eye-catching is that among the new drugs approved by the FDA in 2023, antibody drugs occupy a prominent position, including China’s domestic PD-1 monoclonal antibodies, which brings new hope to the medical community.

Among these 55 new drugs, oncology once again became the most approved treatment area, fully reflecting the medical community’s in-depth research on cancer treatment. At the same time, the fields of neurology and infectious diseases have also been recognized by the FDA, providing more treatment options for patients. The emergence of new drugs will promote the rapid development of medical technology and further promote progress in the health field.

It is worth mentioning that 2023 has also become a year of significant progress in the field of rare diseases, providing patients with new treatment options. Pfizer performed well this year. Not only did it become the company with the most approvals, it also launched a number of highly anticipated new products, covering multiple disease fields such as tumors, immunity, infection, and the nervous system.

In this dynamic year of medical innovation, it is worth noting that there are 6 new drugs that belong to the peptide drug category. They are:

1.Daybue (Trofinetide, Trofinetide)

  • Developer: Acadia Pharmaceuticals
  • Approval time: 2023-03-10
  • Indications: Rett syndrome
  • Delivery method: Oral solution (200 mg/ml), specific dosage is based on body weight
  • Introduction: It is used to treat Rett syndrome and is the first approved therapy for Rett syndrome. It exerts neuroprotective effects by enhancing synaptic activity and restoring synaptic structure.

2.Rezzayo (Rezafungin, Rezafungin)

  • Developer: Melinta Therapeutics/Cidara Therapeutics
  • Approval time: 2023-03-22
  • Indications: Candidemia and invasive candidiasis
  • Delivery method: Intravenous injection (200 mg once weekly)
  • Introduction: For the treatment of candidemia and invasive candidiasis, it is the first new treatment option approved for this indication in more than a decade.

3.Paxlovid (nirmatrelvir&ritonavir)

  • Developer: Pfizer
  • Approval time: 2023-05-25
  • Indications: Covid-19
  • Mode of delivery: Oral
  • Introduction: It is used to treat COVID-19 and reduce the severity of the disease by preventing the virus from multiplying. It contains two peptidomimetic molecules, nirmatrelvir and ritonavir.

4.Posluma (flotufolastat F 18)

  • Developer: Blue Earth Diagnostics
  • Approval time: 2023-05-25
  • Indications: Positron emission tomography imaging in patients with prostate cancer
  • Delivery method: Intravenous injection
  • Introduction: Positron emission tomography imaging for prostate cancer patients using PSMA targeting components for imaging.

5.Aphexda (Motixafortide, motixafortide)

  • Developer: BioLineRx
  • Approval time: 2023-09-08
  • Indications: Collection and subsequent autologous transplantation in patients with multiple myeloma
  • Delivery method: Subcutaneous injection
  • Introduction: For the collection and subsequent autologous transplantation of patients with multiple myeloma, stem cells are mobilized into the peripheral blood by CXCR4 antagonists.

6.Zilbrysq(Zilucoplan)

  • Developer: UCB
  • Approval time: 2023-10-17
  • Indications: Generalized myasthenia gravis in adults
  • Delivery method: Subcutaneous injection
  • Introduction: It is the first once-daily subcutaneous injection of gMG-targeted C5 complement inhibitor for the treatment of generalized myasthenia gravis in adults.

The approval of new drugs this year witnessed the joint efforts of medical research and industrial development, providing patients with more innovative treatments and writing a new chapter for building a healthier future.

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date*
55 Wainua eplontersen 12/21/2023 To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
54 Filsuvez birch triterpenes 12/18/2023 To treat wounds associated with dystrophic and junctional epidermolysis bullosa
53 Fabhalta iptacopan 12/5/2023 To treat paroxysmal nocturnal hemoglobinuria
52 Ogsiveo nirogacestat 11/27/2023 To treat adults with progressing desmoid tumors who require systemic treatment
51 Truqap capivasertib 11/16/2023 To treat breast cancer that meets certain disease criteria
50 Ryzneuta efbemalenograstim alfa-vuxw 11/16/2023 To treat neutropenia
49 Augtyro repotrectinib 11/15/2023 To treat ROS1-positive non-small cell lung cancer
48 Defencath taurolidine, heparin 11/15/2023 To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter
47 Fruzaqla fruquintinib 11/8/2023 To treat refractory, metastatic colorectal cancer
46 Loqtorzi toripalimab-tpzi 10/27/2023 To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies
45 Omvoh mirikizumab-mrkz 10/26/2023 To treat ulcerative colitis
44 Agamree vamorolone 10/26/2023 To treat Duchenne muscular dystrophy
43 Bimzelx bimekizumab 10/17/2023 To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
42 Zilbrysq zilucoplan 10/17/2023 To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
41 Velsipity etrasimod 10/12/2023 To treat moderately to severely active ulcerative colitis in adults
40 Rivfloza nedosiran 9/29/2023 To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function
39 Pombiliti cipaglucosidase alfa-atga 9/28/2023 To treat late-onset Pompe disease
38 Exxua gepirone 9/22/2023 To treat major depressive disorder
37 Ojjaara momelotinib 9/15/2023 To treat intermediate or high-risk myelofibrosis in adults with anemia
36 Aphexda motixafortide 9/8/2023 To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma
35 Veopoz pozelimab-bbfg 8/18/2023 To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease
34 Sohonos palovarotene 8/16/2023 To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva
33 Elrexfio elranatamab-bcmm 8/14/2023 To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy
32 Talvey talquetamab-tgvs 8/9/2023 To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies
31 Izervay avacincaptad pegol 8/4/2023 To treat geographic atrophy secondary to age-related macular degeneration
30 Zurzuvae zuranolone 8/4/2023 To treat postpartum depression
29 Xdemvy lotilaner 7/25/2023 To treat Demodex blepharitis
28 Vanflyta quizartinib 7/20/2023 To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria
27 Beyfortus nirsevimab-alip 7/17/2023 To prevent respiratory syncytial virus (RSV) lower respiratory tract disease
26 Ngenla somatrogon-ghla 6/27/2023 To treat growth failure due to inadequate secretion of endogenous growth hormone
25 Rystiggo rozanolixizumab-noli 6/26/2023 To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive
24 Litfulo ritlecitinib 6/23/2023 To treat severely patchy hair loss
23 Columvi glofitamab-gxbm 6/15/2023 To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy
22 Inpefa sotagliflozin 5/26/2023 To treat heart failure
21 Posluma flotufolastat F 18 5/25/2023 To use with positron emission tomography imaging in certain patients with prostate cancer
20 Paxlovid nirmatrelvir, ritonavir 5/25/2023 To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19
19 Xacduro sulbactam, durlobactam 5/23/2023 To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
18 Epkinly epcoritamab-bysp 5/19/2023 To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy
17 Miebo perfluorhexyloctane 5/18/2023 To treat signs and symptoms of dry eye disease
16 Veozah fezolinetant 5/12/2023 To treat moderate to severe hot flashes caused by menopause
15 Elfabrio pegunigalsidase alfa-iwxj 5/9/2023 To treat confirmed Fabry disease
14 Qalsody tofersen 4/25/2023 To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation
13 Joenja leniolisib 3/24/2023 To treat activated phosphoinositide 3-kinase delta syndrome
12 Rezzayo rezafungin 3/22/2023 To treat candidemia and invasive candidiasis
11 Zynyz retifanlimab-dlwr 3/22/2023 To treat metastatic or recurrent locally advanced Merkel cell carcinoma
10 Daybue trofinetide 3/10/2023 To treat Rett syndrome
9 Zavzpret zavegepant 3/9/2023 To treat migraine
8 Skyclarys omaveloxolone 2/28/2023 To treat Friedrich’s ataxia
7 Filspari sparsentan 2/17/2023 To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
6 Lamzede velmanase alfa-tycv 2/16/2023 To treat non-central nervous system manifestations of alpha-mannosidosis
5 Jesduvroq daprodustat 2/1/2023 To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
4 Orserdu elacestrant 1/27/2023 To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
3 Jaypirca pirtobrutinib 1/27/2023 To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor
2 Brenzavvy bexagliflozin 1/20/2023 To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
1 Leqembi lecanemab-irmb 1/6/2023 To treat Alzheimer’s disease