---
title: Novel FDA Drug Approvals - 1st Quarter of 2023 - PharmaKB Report
description: Novel FDA Drug Approvals - PharmaKB Report - Q1 2023
image: https://www.pharmakb.com/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png
---

# Novel FDA Drug Approvals - 1st Quarter of 2023 - PharmaKB Report

 Apr 1, 2023 1:10:00 PM

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The Pharmaceutical KnowledgeBase ([PharmaKB.com](https://pharmakb.com)) provides research and financial intelligence about companies and their approved drugs as well as drug candidates in clinical trials. In this quarterly PharmaKB report, we provide an update about novel drugs approved by the US FDA in of this year.  By referencing new drugs as “novel” the FDA is confirming that the medicine being approved contains ingredients and/or a mechanism of action that the FDA hasn’t previously approved. 

2023 | [January](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-q1-2023#a1) | [February](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-q1-2023#a2) | [March ](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-q1-2023#a3)

 

 

**January 2023 – Novel FDA Drug Approvals**

**Lecanemab**

- **Drug**: [Lecanemab](https://app.pharmakb.com/drugs/Lecanemab)
- **Trade name**: Leqembi
- **Therapeutic Area**: Alzheimer’s Disease (nervous system diseases MeSH [D009422](https://www.ncbi.nlm.nih.gov/mesh/?term=D009422) | mental disorders MeSH [D001523](https://www.ncbi.nlm.nih.gov/mesh/?term=D001523))
- **Manufacturer**: Eisai
- **FDA Approval Date**: January 6, 2023 (via [FDA Accelerated Approval Program](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval))
- **Classification**: Antibody
- **Drug Class**: Monoclonal antibodies
- **Clinical Trials**: [https://app.pharmakb.com/drugs/Lecanemab#clinical](https://app.pharmakb.com/drugs/Lecanemab#clinical)
- **Adverse Events:** [https://app.pharmakb.com/drugs/Lecanemab#safety](https://app.pharmakb.com/drugs/Lecanemab#safety)
- **Description**: Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody medication used for the treatment of Alzheimer's disease. Lecanemab is an amyloid beta-directed antibody, delivered via intravenous infusion.
- **FDA News Release**: [https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment](https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment)

**Bexagliflozin**

- **Drug**: [Bexagliflozin](https://app.pharmakb.com/drugs/Bexagliflozin)
- **Trade name**: Brenzavvy
- **Therapeutic Area**: Type 2 diabetes mellitus (MeSH [D003924)](https://www.ncbi.nlm.nih.gov/mesh/?term=D003924) and essential hypertension (MeSH [https://www.ncbi.nlm.nih.gov/mesh/?term=D000075222](https://www.ncbi.nlm.nih.gov/mesh/?term=D000075222))
- **Manufacturer**: TheracosBio
- **FDA Approval Date**: January 23, 2023
- **Classification**: Small molecule
- **Drug Class**: Phlorozin derivatives, phenolic glycosides
- **Clinical Trials**: [https://app.pharmakb.com/drugs/Bexagliflozin#clinical](https://app.pharmakb.com/drugs/Bexagliflozin#clinical) 
- **Adverse Events:** [https://app.pharmakb.com/drugs/Bexagliflozin#safety](https://app.pharmakb.com/drugs/Bexagliflozin#safety) 
- **Description**: Brenzavvy (bexagliflozin) is a small molecule pharmaceutical approved to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. This medicine is administered orally in 20 milligram tablet form.
- **FDA News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214373s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214373s000lbl.pdf)

**Pirtobrutinib**

- **Drug: **[Pirtobrutinib](https://app.pharmakb.com/drugs/Pirtobrutinib)
- **Trade name**:  Jaypirca
- **Therapeutic Area**: Relapsed or refractory mantle cell lymphoma (MCL) (MeSH [D020522](https://www.cdek.liu.edu/mesh/D020522/))
- **Manufacturer**: Eli Lilly and Company
- **FDA Approval Date**: January 27, 2023 (via [FDA Accelerated Approval Program](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval))
- **Classification**: Small molecule
- **Drug Class**: Tyrosine kinase inhibitors: tyrosine kinase inhibitors Bruton's (Btk) inhibitors
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Pirtobrutinib#clinical](https://app.pharmakb.com/drugs/Pirtobrutinib#clinical)
- **Adverse Events: **[https://app.pharmakb.com/drugs/Pirtobrutinib#safety](https://app.pharmakb.com/drugs/Pirtobrutinib#safety)** **
- **Description**: Pirtobrutinib, sold under the brand name Jaypirca, is an anticancer medication that is used to treat mantle cell lymphoma. It inhibits B cell lymphocyte proliferation and survival by binding and inhibiting Bruton's tyrosine kinase (BTK). It is taken by mouth.
- **FDA News Release**: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-relapsed-or-refractory-mantle-cell-lymphoma](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-relapsed-or-refractory-mantle-cell-lymphoma) 

**Elacestrant **

- **Drug: **[Elacestrant](https://app.pharmakb.com/drugs/Elacestrant)
- **Trade name**:  Orserdu
- **Therapeutic Area**: Breast cancer (MeSH [D001943](https://www.ncbi.nlm.nih.gov/mesh/?term=D001943))
- **Manufacturer**: Stemline Therapeutics
- **FDA Approval Date**: January 27, 2023
- **Classification**: Small molecule
- **Drug Class**: Estrogens; estrogen antagonists
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Elacestrant#clinical](https://app.pharmakb.com/drugs/Elacestrant#clinical)
- **Adverse Events: **[https://app.pharmakb.com/drugs/Elacestrant#safety](https://app.pharmakb.com/drugs/Elacestrant#safety)
- **Description**: Elacestrant, sold under the brand name Orserdu, is an anticancer medication which is used in the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. It is taken by mouth.
- **FDA News Release**: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer) 

 

 

**February 2023 – Novel FDA Drug Approvals**

**Daprodustat**

- **Drug**: [Daprodustat](https://app.pharmakb.com/drugs/Daprodustat)
- **Trade name**: Jesduvroq
- **Therapeutic Areas**: Anemia MeSH [D000740](https://www.ncbi.nlm.nih.gov/mesh/?term=D000740); Allergic bronchopulmonary aspergillosis MeSH [D001229](https://www.ncbi.nlm.nih.gov/mesh/?term=D001229)
- **Manufacturer**: GSK
- **FDA Approval Date**: February 1, 2023 (via New Drug Application)
- **Classification**: Small molecule
- **Drug Class**: enzyme inhibitors: hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors
- **Clinical Trials**: [https://app.pharmakb.com/drugs/Daprodustat#clinical](https://app.pharmakb.com/drugs/Daprodustat#clinical)   
- **Adverse Events: **[https://app.pharmakb.com/drugs/Daprodustat#safety](https://app.pharmakb.com/drugs/Daprodustat#safety)
- **Description**: Daprodustat, sold under the brand name Jesduvroq and Duvroq, among others, is a medication that is used for the treatment of anemia due to chronic kidney disease. It is a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is taken by mouth.
- **FDA News Release**: [https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis) 

**Velmanase alfa-tycv**

- **Drug**: [Velmanase alfa](https://app.pharmakb.com/drugs/Velmanase%20alfa)
- **Trade name**: Lamzede
- **Therapeutic Areas**: Hereditary congenital and neonatal diseases and abnormalities MeSH [D009358](https://www.ncbi.nlm.nih.gov/mesh/?term=D009358); nutritional and metabolic diseases MeSH [D009750](https://www.ncbi.nlm.nih.gov/mesh/?term=D009750).
- **Manufacturer**: Chiesi Farmaceutici
- **FDA Approval Date**: February 16, 2023
- **Classification**: Enzyme
- **Drug Class**: Enzymes
- **Clinical Trials**: [https://app.pharmakb.com/drugs/Velmanase%20alfa#clinical](https://app.pharmakb.com/drugs/Velmanase%20alfa#clinical)
- **Adverse Events: **[https://app.pharmakb.com/drugs/Velmanase%20alfa#safety](https://app.pharmakb.com/drugs/Velmanase%20alfa#safety)
- **Description**: Velmanase alfa, sold under the brand name Lamzede, is a medication used for the treatment of alpha-mannosidosis. Velmanase alfa is a recombinant human lysosomal alpha-mannosidase. It is administered by infusion.
- **FDA News Release**: [https://www.fda.gov/news-events/press-announcements/fda-roundup-february-17-2023](https://www.fda.gov/news-events/press-announcements/fda-roundup-february-17-2023)

**Sparsentan**

- **Drug: **[Sparsentan](https://app.pharmakb.com/drugs/Sparsentan)
- **Trade name**:  Filspari
- **Therapeutic Areas**: Iga glomerulonephritis MeSH [D005922](https://meshb.nlm.nih.gov/record/ui?ui=D005922); Focal segmental glomerulosclerosis MeSH [D005923](https://meshb.nlm.nih.gov/record/ui?ui=D005923).
- **Manufacturer**: Travere Therapeutics
- **FDA Approval Date**: February 17, 2023 (via [FDA Accelerated Approval Program](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval))
- **Classification**: Small molecule
- **Drug Class**: Endothelin receptor antagonists
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Sparsentan#clinical](https://app.pharmakb.com/drugs/Sparsentan#clinical)
- **Adverse Events: **[https://app.pharmakb.com/drugs/Sparsentan#safety](https://app.pharmakb.com/drugs/Sparsentan#safety)
- **Description**: Sparsentan, sold under the brand name Filspari, is a medication used for the treatment of primary immunoglobulin A nephropathy. Sparsentan is an endothelin and angiotensin II receptor antagonist. It is taken by mouth.
- **FDA News Release**: [https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216403Orig1s000ltr.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216403Orig1s000ltr.pdf)

**Omaveloxolone**

- **Drug: **[Omaveloxolone](https://app.pharmakb.com/drugs/Omaveloxolone)
- **Trade name**:  Skyclarys
- **Therapeutic Areas**: Friedreich’s ataxia MeSH [D005621](https://meshb.nlm.nih.gov/record/ui?ui=D005621)
- **Manufacturer**: Reata Pharmaceuticals
- **FDA Approval Date**: February 28, 2023 (via [FDA Accelerated Approval Program](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval))
- **Classification**: Small molecule
- **Drug Class**: Steroids (not prednisolone derivatives)
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Omaveloxolone#clinical](https://app.pharmakb.com/drugs/Omaveloxolone#clinical)
- **Adverse Events: **[https://app.pharmakb.com/drugs/Omaveloxolone#safety](https://app.pharmakb.com/drugs/Omaveloxolone#safety) 
- **Description**: Omaveloxolone, sold under the brand name Skyclarys, is a medication used for the treatment of Friedreich's ataxia. It is taken by mouth.
- **FDA News Release**: [https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia) 

 

 

**March 2023 – Novel FDA Drug Approvals**

**Zavegepant**

- **Drug**:  [Zavegepant](https://app.pharmakb.com/drugs/Zavegepant)
- **Trade name**:  Zavzpret
- **Therapeutic Areas**:  Migraine disorders MeSH [D008881](https://www.ncbi.nlm.nih.gov/mesh/?term=D008881); Covid-19 MeSH [D000086382](https://www.ncbi.nlm.nih.gov/mesh/?term=D000086382)
- **Manufacturer**:  Mylan
- **FDA Approval Date**:  March 9, 2023
- **Classification**:  Small molecule 
- **Drug Class**:  Calcitonin gene-related peptide receptor antagonists
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Zavegepant#clinical](https://app.pharmakb.com/drugs/Zavegepant#clinical)
- **Adverse Events:  **[https://app.pharmakb.com/drugs/Zavegepant#safety](https://app.pharmakb.com/drugs/Zavegepant#safety)
- **Description**:  Zavegepant, sold under the trade name Zavzpret, isZavegepant is a calcitonin gene-related peptide receptor antagonist. It is sprayed into the nose. It is sold by Pfizer.
- **FDA News Release**:  [https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216386Orig1s000ltr.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216386Orig1s000ltr.pdf)

**Trofinetide**

- **Drug**:  [Trofinetide](https://app.pharmakb.com/drugs/Trofinetide)
- **Trade name**:  Daybue
- **Therapeutic Areas**:  Rett syndrome MeSH [D015518](https://www.ncbi.nlm.nih.gov/mesh/?term=D015518); brain injuries MeSH [D001930](https://www.ncbi.nlm.nih.gov/mesh/?term=D001930); fragile x syndrome MeSH [D005600](https://www.ncbi.nlm.nih.gov/mesh/?term=D005600)
- **Manufacturer**:  Acadia Pharmaceuticals
- **FDA Approval Date**:  March 10, 2023
- **Classification**:  Small molecule
- **Drug Class**:  Peptides: neuropeptide Y (NPY) receptors and analogues
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Trofinetide#clinical](https://app.pharmakb.com/drugs/Trofinetide#clinical) 
- **Adverse Events:  **[https://app.pharmakb.com/drugs/Trofinetide#safety](https://app.pharmakb.com/drugs/Trofinetide#safety) 
- **Description**:  Trofinetide, sold under the brand name Daybue, is a medication used for the treatment of Rett syndrome. It is taken by mouth.
- **FDA News Release**:  [https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-rett-syndrome](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-rett-syndrome)

**Zynyz**

- **Drug**:  [Zynyz](https://app.pharmakb.com/drugs/Retifanlimab)
- **Trade name**:  Retifanlimab
- **Therapeutic Areas**:  Non-small-cell lung carcinoma MeSH [D002289](https://www.ncbi.nlm.nih.gov/mesh/?term=D002289); squamous cell carcinoma of head and neck MeSH [D000077195](https://www.ncbi.nlm.nih.gov/mesh/?term=D000077195); Head and neck neoplasms MeSH [D006258](https://www.ncbi.nlm.nih.gov/mesh/?term=D006258)
- **Manufacturer**:  Incyte Corporation
- **FDA Approval Date**:  March 22, 2023
- **Classification**:  Antibody
- **Drug Class**:  Monoclonal antibodies
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Retifanlimab#clinical](https://app.pharmakb.com/drugs/Retifanlimab#clinical)
- **Adverse Events:  **[https://www.pharmakb.com/drug-report/retifanlimab#safety](https://www.pharmakb.com/drug-report/retifanlimab#safety)
- **Description**:  Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma. Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
- **FDA News Release**:  [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-zynyz-retifanlimab-dlwr-metastatic-or-recurrent-locally](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-zynyz-retifanlimab-dlwr-metastatic-or-recurrent-locally)

**Rezafungin**

- **Drug**:  [Rezafungin](https://www.pharmakb.com/drug-report/rezafungin)
- **Trade name**:  Rezzayo
- **Therapeutic Areas**: Mycoses MeSH [D009181](https://www.ncbi.nlm.nih.gov/mesh/?term=D009181); candidemia MeSH [D058387](https://www.ncbi.nlm.nih.gov/mesh/?term=D058387); invasive candidiasis MeSH [D058365](https://www.ncbi.nlm.nih.gov/mesh/?term=D058365); fungemia [D016469](https://www.ncbi.nlm.nih.gov/mesh/?term=D016469)
- **Manufacturer**:  Cidara Therapeutics
- **FDA Approval Date**:  March 22, 2023
- **Classification**:  Small molecule 
- **Drug Class**:  Antifungal antibiotics
- **Clinical Trials**:  [https://app.pharmakb.com/drugs/Retifanlimab#clinical](https://app.pharmakb.com/drugs/Retifanlimab#clinical)
- **Adverse Events:  **[https://app.pharmakb.com/drugs/Retifanlimab#safety](https://app.pharmakb.com/drugs/Retifanlimab#safety)
- **Description**:  Rezafungin, sold under the name Rezzayo, is an antifungal drug of the echinocandin class.
- **FDA News Release**:  [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000Approv.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000Approv.pdf)

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## Read On

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### [Novel FDA Drug Approvals - 2nd Quarter of 2023 - PharmaKB Report](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2023q2)

[![](https://www.pharmakb.com/hs-fs/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png?width=352&name=FDA%20Approved%20PharmaKB%20Report%20Logo-2.png) ](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q1)

### [Novel FDA Drug Approvals - 1st Quarter of 2024 - PharmaKB Report](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2024q1)

[![](https://www.pharmakb.com/hs-fs/hubfs/FDA%20Approved%20PharmaKB%20Report%20Logo-2.png?width=352&name=FDA%20Approved%20PharmaKB%20Report%20Logo-2.png) ](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2023q3)

### [Novel FDA Drug Approvals - 3rd Quarter of 2023 - PharmaKB Report](https://www.pharmakb.com/blog/novel-fda-drug-approvals-pharmakb-report-2023q3)

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  "@context" : "https://schema.org",
  "@id" : "https://www.pharmakb.com/#website",
  "@type" : "WebSite",
  "inLanguage" : "en-US",
  "name" : "PharmaKB",
  "potentialAction" : {
    "@type" : "SearchAction",
    "query-input" : "required name=search_term_string",
    "target" : "https://www.pharmakb.com/search?s={search_term_string}"
  },
  "publisher" : {
    "@id" : "https://www.pharmakb.com/#organization"
  },
  "url" : "https://www.pharmakb.com"
}
```

```json
{
  "@context" : "https://schema.org",
  "@id" : "https://www.pharmakb.com/hs-fs/hubfs/PharmaKBWhite%20on%20Blue.png?width=2526&name=PharmaKBWhite%20on%20Blue.png",
  "@type" : "ImageObject",
  "caption" : "PharmaKB Logo",
  "height" : "217",
  "inLanguage" : "en-US",
  "url" : "https://www.pharmakb.com/hs-fs/hubfs/PharmaKBWhite%20on%20Blue.png?width=2526&name=PharmaKBWhite%20on%20Blue.png",
  "width" : "979"
}
```

```json
{
  "@context" : "https://schema.org",
  "@id" : "https://www.pharmakb.com/#webpage",
  "@type" : "WebPage",
  "about" : {
    "@id" : "https://www.pharmakb.com/#organization"
  },
  "dateModified" : "2022-04-20T10:26:05-07:00",
  "datePublished" : "2019-07-11T06:43:10-07:00",
  "inLanguage" : "en-US",
  "isPartOf" : {
    "@id" : "https://www.pharmakb.com/#website"
  },
  "name" : "PharmaKB - Real-Time Drug Data",
  "primaryImageOfPage" : {
    "@id" : "https://www.pharmakb.com/hs-fs/hubfs/PharmaKBWhite%20on%20Blue.png?width=2526&name=PharmaKBWhite%20on%20Blue.png"
  },
  "url" : "https://www.pharamakb.com/"
}
```

```json
{
  "@context" : "https://schema.org",
  "@id" : "https://www.pharmakb.com/#author",
  "@type" : "Person",
  "image" : {
    "@id" : "https://secure.gravatar.com/avatar/a11e9761d6aa9db0d579cc1f6f5dd9d2?s=96&amp;d=blank&amp;r=g",
    "@type" : "ImageObject",
    "caption" : "baeprod",
    "inLanguage" : "en-US",
    "url" : "https://secure.gravatar.com/avatar/a11e9761d6aa9db0d579cc1f6f5dd9d2?s=96&amp;d=blank&amp;r=g"
  },
  "name" : "baeprod",
  "sameAs" : [ "https://www.biometadata.com" ],
  "worksFor" : {
    "@id" : "https://www.pharmakb.com/#organization"
  }
}
```

```json
{
  "@context" : "https://schema.org",
  "@id" : "https://www.pharmakb.com/#richSnippet",
  "@type" : "",
  "author" : {
    "@id" : "https://www.pharmakb.com/#author"
  },
  "dateModified" : "2022-04-20T10:26:05-07:00",
  "datePublished" : "2019-07-11T06:43:10-07:00",
  "description" : "PharmaKB",
  "headline" : "PharmaKB - The Pharmaceutical KnowledgeBase",
  "image" : {
    "@id" : "https://www.pharmakb.com/wp-content/uploads/2021/04/BioHarmony-Logo-Blue.png"
  },
  "inLanguage" : "en-US",
  "isPartOf" : {
    "@id" : "https://www.pharmakb.com/#webpage"
  },
  "mainEntityOfPage" : {
    "@id" : "https://www.pharmakb.com/#webpage"
  },
  "name" : "PharmaKB - Real-Time Drug Data",
  "publisher" : {
    "@id" : "https://www.pharmakb.com/#organization"
  }
}
```