2022 Drug Approvals

In 2022 there were 36 novel small molecule and large molecule drugs approved by the FDA, including 18 first-in-class drug approvals. This page contains posters and reviews of the science behind each molecule including the:

• 19 small molecule drug approvals (excluding atoms)
• 17 large molecule drug approvals (click to jump to poster)
• 9 first in class small molecule drug approvals (click to jump to poster)
• 10 first in class large molecule drug approvals (click to jump to poster)

2022 Novel Small Molecule Drug Approvals

You can download our compilation of all 19 small molecule drug approvals from 2022 below, which includes structures, drug targets and mechanisms of action, doses and routes of administration, and indication. You can also find past examples of our 2021 Small Molecule Approvals Poster, 2020 Small Molecule Approvals Poster, and 2019 Small Molecule Approvals Poster online, and you can read a more in-depth review of each individual molecule by clicking on the links to the molecules below:

You can read a review of each individual molecule by clicking on the links to the molecules below:

1. Quviviq (daridorexant): oral dual orexin receptor blocker (OX1/OX2); for insomnia in adults; antagonizes orexin neuropeptide mediated wakefulness.
2. Cibinqo (abrocitinib): oral JAK1-selective inhibitor (9-28x); 100 or 200 mg QD; for refractory atopic dermatitis in adults; reduces inflammatory cytokines.
3. Pyrukynd (mitapivat): an oral pyruvate kinase activator approved for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
4. Vonjo (pacritinib): an oral (200 mg BID) JAK2/IRAK1 kinase inhibitor with selectivity over JAK1 for treatment of myelofibrosis
5. Ztalmy (ganaxolone): an oral GABA-A receptor modulator to treat seizures in cyclin-dependent kinase-like 5 deficiency disorder
6. Pluvicto (lutetium Lu 177 vipivotide tetraxetan): an injectable, therapeutically active radioligand to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
7. Camzyos (mavacamten): an oral cardiac myosin inhibitor for certain classes of obstructive hypertrophic cardiomyopathy
8. Vivjoy (oteseconazole): an oral antifungal for reducing the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential
9. Voquezna (vonoprazan): a potassium-competitive acid blocker (PCAB) for Helicobacter pylori infection
10. Vtama (tapinarof): an aryl hydrocarbon receptor (AhR) agonist for plaque psoriasis
11. Sotyktu (deucravacitinib): a first-in-class oral, allosteric tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis
12. Terlivaz (terlipressin): injectable vasopressin receptor agonist for hepatorenal syndrome
13. Elucirem (gadopiclenol): gadolinium-based contrast agent for MRI imaging of lesions with abnormal vascularity
14. Omlonti (omidenepag isopropyl ophthalmic solution): a prostaglandin E2 (EP2) receptor agonist for elevated intraocular pressure in open‑angle glaucoma or ocular hypertension
15. Relyvrio (sodium phenylbutyrate/taurursodiol*): oral treatment for amyotrophic lateral sclerosis (ALS)
16. Lytgobi (futibatinib): oral fibroblast growth factor receptor 1-4 (FGFR1-4) irreversible inhibitor for iCCA with FGFR2 rearrangements
17. Rezlidhia (olutasidenib): oral IDH1 inhibitor for R/R AML with susceptible IDH1 mutation
18. Krazati (adagrasib): irreversible KRAS^G12C inhibitor for KRAS G12C-mutated NSCLC after at least one prior systemic therapy
19. Sunlenca (lenacapavir): HIV-1 capsid inhibitor for multi-drug resistant HIV

2022 Novel Large Molecule Drug Approvals

You can download our compilation of all 17 large molecule drug approvals from 2022 below, which includes structural illustrations, drug targets and mechanisms of action, doses and routes of administration, and indication. You can also find past examples of our 2021 Large Molecule Approvals Review, 2020 Large Molecule Approvals Compilation and 2019 Large Molecule Approvals Poster online. Additionally you can read an in-depth scientific review of each individual molecule by clicking on the links to the molecules below.

You can read a review of each individual molecule by clicking on the links to the molecules below:

1. Kimmtrak (tebentafusp): injectable bispecific gp100 peptide-HLA-directed CD3 T cell engager; for treating patients with HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma; induces lysis of uveal cancer cells by stimulating T cells to release inflammatory cytokines and cytolytic proteins
2. Vabysmo (faricimab): injectable VEGF and Ang-2 inhibitor; for treating nAMD and DME; inhibits neovascularization and promotes vascular stability.
3. Enjaymo (sutimlimab): An injectable classical complement pathway inhibitor (IgG mAb targeting C1s) approved for decreasing red blood cell (RBC) transfusions in adults with cold agglutinin disease (CAD)
4. Opdualag (nivolumab and relatlimab*): IV combination of nivolumab (PD-1 blocking antibody) and the novel relatlimab (LAG-3 blocking antibody) to treat unresectable or metastatic melanoma
5. Mounjaro (tirzepatide): a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist for improving blood sugar control in diabetes, prescribed in addition to diet and exercise
6. Amvuttra (vutrisiran): a small interfering RNA (siRNA) for polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis in adults
7. Xenpozyme (olipudase alfa): a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for non–CNS manifestations of acid sphingomyelinase deficiency (ASMD)
8. Spevigo (spesolimab-sbzo): an injectable interleukin-36 receptor antagonist for generalized pustular psoriasis flares
9. Daxxify (daxibotulinumtoxinA-lanm): an injectable, long-acting acetylcholine release inhibitor and neuromuscular blocking agent for moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
10. Rolvedon (eflapegrastim): an rhG‐CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker for infection in cancer patients
11. Imjudo (tremelimumab): anti-cytotoxic T-lymphocyte-associated protein 4 (CLTA-4) antibody for unresectable hepatocellular carcinoma (in combination with durvalumab)
12. Tecvayli (teclistamab-cqyv): first-in-class bispecific T-cell engager antibody targeting CD3 receptor and B-cell maturation antigen (BCMA) for R/R MM after at least four lines of prior therapy
13. Elahere (mirvetuximab soravtansine-gynx): anti-folate receptor 1 (FOLR1) antibody conjugated via clevable linker (sulfo-SPDB) to cytoxic maytansinoid DM4 targeting tubilin for recurrent ovarian cancer
14. Tzield (teplizumab-mzwv): first-in-class anti-CD3 receptor antibody that delays the onset of Stage 3 Type 1 diabetes
15. Lunsumio (mosunetuzumab-axgb): a bispecific CD20-directed CD3 T-cell engager for R/R follicular lymphoma
16. Briumvi (ublituximab-xiiy): an anti-CD20 monoclonal antibody for relapsing multiple sclerosis
17. NexoBrid (anacaulase-bcdb): a topical formulation of proteolytic enzymes enriched in bromelain for removing eschar caused by thermal burns

First-in-Class Small Molecule Drug Approvals of 2022

You can download our compilation of the 9 first-in-class small molecule drug approvals from 2022 below, which includes structures, drug targets and mechanisms of action, doses and routes of administration, and indication.

You can read a review of each individual molecule by clicking on the links to the molecules below:

• Sunlenca (lenacapavir): the first approved drug targeting HIV-1 capsid, indicated for multi-drug resistant HIV with an impressive bi-annual dosing regimen (Gilead Sciences)
• Sotyktu (deucravacitinib): the first approved de novo deuterated drug – an oral, allosteric tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis (BMS)
• Ztalmy (ganaxolone): the first neurosteroid to be studied for epilepsy, approved for treating seizures in cyclin-dependent kinase-like 5 deficiency disorder, an oral GABA-A receptor modulator (Marinus Pharmaceuticals)
• Pyrukynd (mitapivat): the first approved therapeutic for pyruvate kinase (PK) deficiency – an oral pyruvate kinase activator that improves hemolytic anemia (Agios)
• Pluvicto (lutetium Lu 177 vipivotide tetraxetan): the first approved radioligand that binds to cancer cells via a PSMA-targeting peptide ligand, approved for PSMA-positive metastatic castration-resistant prostate cancer following other therapies (Novartis)
• Terlivaz (terlipressin):  the first and only approved drug for hepatorenal syndrome, an injectable vasopressin receptor agonist (Mallinckrodt Pharmaceuticals)
• Voquezna (vonoprazan): the first potassium-competitive acid blocker that acts via reversible potassium-competitive ion binding, approved for Helicobacter pylori infection (Phathom Pharmaceuticals)
• Camzyos (mavacamten): the first inhibitor of the motor protein cardiac myosin, approved for certain classes of obstructive hypertrophic cardiomyopathy (BMS)
• Vtama (tapinarof): the first topical treatment approved for psoriasis in over 25 years, an aryl hydrocarbon receptor (AhR) agonist (Dermavant Sciences)

First-in-Class Large Molecule Drug Approvals of 2022

You can download our compilation of the 10 first-in-class large molecule drug approvals from 2022 below, which includes structural illustrations, drug targets and mechanisms of action, doses and routes of administration, and indication.

You can read a review of each individual molecule by clicking on the links to the molecules below:

1. Kimmtrak (tebentafusp): injectable bispecific gp100 peptide-HLA-directed CD3 T cell engager; for treating patients with HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma; induces lysis of uveal cancer cells by stimulating T cells to release inflammatory cytokines and cytolytic proteins
2. Enjaymo (sutimlimab): An injectable classical complement pathway inhibitor (IgG mAb targeting C1s) approved for decreasing red blood cell (RBC) transfusions in adults with cold agglutinin disease (CAD)
3. Opdualag (nivolumab and relatlimab*): IV combination of nivolumab (PD-1 blocking antibody) and the novel relatlimab (LAG-3 blocking antibody) to treat unresectable or metastatic melanoma
4. Mounjaro (tirzepatide): a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist for improving blood sugar control in diabetes, prescribed in addition to diet and exercise
5. Xenpozyme (olipudase alfa): a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for non–CNS manifestations of acid sphingomyelinase deficiency (ASMD)
6. Spevigo (spesolimab-sbzo): an injectable interleukin-36 receptor antagonist for generalized pustular psoriasis flares
7. Tecvayli (teclistamab-cqyv): first-in-class bispecific T-cell engager antibody targeting CD3 receptor and B-cell maturation antigen (BCMA) for R/R MM after at least four lines of prior therapy
8. Elahere (mirvetuximab soravtansine-gynx): anti-folate receptor 1 (FOLR1) antibody conjugated via clevable linker (sulfo-SPDB) to cytoxic maytansinoid DM4 targeting tubilin for recurrent ovarian cancer
9. Tzield (teplizumab-mzwv): first-in-class anti-CD3 receptor antibody that delays the onset of Stage 3 Type 1 diabetes
10. Lunsumio (mosunetuzumab-axgb): a bispecific CD20-directed CD3 T-cell engager for R/R follicular lymphoma

Approvals by Month

You can read a review of each individual molecule by clicking on the links to the molecules below:

January 2022

Quviviq (daridorexant), an oral dual orexin receptor blocker (OX1/OX2)

Cibinqo (abrocitinib), an oral JAK1-selective inhibitor

Kimmtrak (tebentafusp), an injectable bispecific gp100 peptide-HLA-directed CD3 T cell engager

Vabysmo (faricimab), an injectable VEGF and Ang-2 inhibitor

February 2022

Vonjo (pacritinib), an oral JAK2/IRAK1 kinase inhibitor

Enjaymo (sutimlimab), a classical complement pathway inhibitor (IgG mAb targeting C1s)

Pyrukynd (mitapivat), an allosteric PKR kinase activator

March 2022

Ztalmy (ganaxolone), an oral GABAA receptor positive allosteric modulator

Pluvicto (lutetium Lu 177 vipivotide tetraxetan), an injectable radioligand

Opdualag (relatlimab* and nivolumab), the novel component relatlimab is a Lag-3 blocking antibody

April 2022

Camzyos (mavacamten), an oral cardiac myosin inhibitor

Vivjoy (oteseconazole), an oral antifungal

May 2022

Voquezna (vonoprazan), a potassium-competitive acid blocker (PCAB)

Mounjaro (tirzepatide), a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist

Vtama (tapinarof), an aryl hydrocarbon receptor (AhR) agonist for plaque psoriasis

June 2022

Amvuttra (vutrisiran), a small interfering RNA (siRNA)

August 2022

Xenpozyme (olipudase alfa), a hydrolytic lysosomal sphingomyelin-specific enzyme

September 2022

Spevigo (spesolimab-sbzo), an injectable interleukin-36 receptor antagonist for generalized pustular psoriasis flares

Daxxify (daxibotulinumtoixnA-lanm), an injectable, long-acting acetylcholine release inhibitor and neuromuscular blocking agent for moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity

Rolvedon (eflapegrastim), an rhG‐CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker for infection in cancer patients

Sotyktu (deucravacitinib), a first-in-class oral, allosteric tyrosine kinase 2 (TYK2) inhibitor

Terlivaz (terlipressin), injectable vasopressin receptor agonist for hepatorenal syndrome

Omlonti (omidenepag isopropyl ophthalmic solution), a prostaglandin E2 (EP2) receptor agonist for elevated intraocular pressure in open‑angle glaucoma or ocular hypertension

Relyvrio (sodium phenylbutyrate/taurursodiol*), oral treatment for amyotrophic lateral sclerosis (ALS)

Lytgobi (futibatinib), oral fibroblast growth factor receptor 1-4 (FGFR1-4) irreversible inhibitor for iCCA with FGFR2 rearrangements

October 2022

Imjudo (tremelimumab), anti-cytotoxic T-lymphocyte-associated protein 4 (CLTA-4) antibody for unresectable hepatocellular carcinoma (in combination with durvalumab)

Tecvayli (teclistamab-cqyv), first-in-class bispecific T-cell engager antibody targeting CD3 receptor and B-cell maturation antigen (BCMA) for R/R MM after at least four lines of prior therapy

November 2022

Elahere (mirvetuximab soravtansine-gynx), anti-folate receptor 1 (FOLR1) antibody conjugated via clevable linker (sulfo-SPDB) to cytoxic maytansinoid DM4 targeting tubilin for recurrent ovarian cancer

Tzield (teplizumab-mzwv), first-in-class anti-CD3 receptor antibody that delays the onset of stage 3 type 1 diabetes

December 2022

Rezlidhia (olutasidenib), oral IDH1 inhibitor for R/R AML with susceptible IDH1 mutation

Krazati (adagrasib), irreversible KRAS^G12C inhibitor for KRAS G12C-mutated NSCLC after at least one prior systemic therapy

Sunlenca (lenacapavir), HIV-1 capsid inhibitor for multi-drug resistant HIV

Lunsumio (mosunetuzumab-axgb), a bispecific CD20-directed CD3 T-cell engager for R/R FL