Pharmetheus · Drug Intelligence

New Drug Watch

Newly approved drugs and first-in-class molecules — curated from FDA approvals and regulatory updates for clinical educators and pharmacology practitioners.

Jan – Apr 2026 14 New Approvals 7 First-in-Class FDA Approved

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Brand Name	Generic Name	Drug Class	Indication	Route
Zycubo	copper histidinate	Copper Replacement Therapy	Menkes Disease (pediatric)	SC
Yuvezzi	carbachol + brimonidine	Dual Ophthalmic Agonist Combo	Presbyopia (adults)	Ophthalmic
Filkri	filgrastim-laha	G-CSF Biosimilar BIOSIM	Chemotherapy-induced neutropenia	SC / IV
Desmoda	desmopressin acetate (oral soln)	Vasopressin Analog — Oral	Central Diabetes Insipidus	Oral
Yuviwel	navepegritide	CNP Analog ★ FIC	Achondroplasia (children 2+)	SC weekly
Adquey	difamilast 1%	Topical PDE-4 Inhibitor ★ FIC	Atopic Dermatitis (ages 2+)	Topical
Loargys	pegzilarginase-nbln	Recombinant Arginase ERT	Arginase 1 Deficiency	IV weekly
Icotyde	icotrokira	Oral IL-23 Receptor Antagonist ★ FIC	Moderate-severe Plaque Psoriasis	Oral daily
Lynavoy	linerixibat	IBAT Inhibitor ★ FIC	Cholestatic Pruritus / PBC	Oral BD
Lifyorli	relacorilan	Selective GCR Modulator	Platinum-resistant Ovarian Cancer	Oral daily
Avlayah	tividenofusp alfa-eknm	Brain-Penetrating I2S ERT	Hunter Syndrome (MPS Type II)	IV weekly
Kresladi	marnetegragene autotemcel	Autologous HSC Gene Therapy ★ FIC	Leukocyte Adhesion Deficiency-I	IV (one-time)
Awiqli	insulin icodec-abae	Ultra-Long-Acting Basal Insulin ★ FIC	Type 2 Diabetes Mellitus	SC weekly
Foundayo	orforgliprion	Non-Peptide Oral GLP-1 RA ★ FIC	Obesity / Overweight	Oral daily

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Zycubo

copper histidinate

Copper Replacement

Indication

Menkes Disease (pediatric)

Mechanism

Delivers copper ions to restore copper-dependent enzyme activity essential for brain development and connective tissue formation.

Dose & Route

SC injection · Individualized dosing

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Yuvezzi

carbachol + brimonidine tartrate

Dual Ophthalmic Agonist

Indication

Presbyopia (adults)

Mechanism

Brimonidine reduces pupil size; carbachol contracts the ciliary muscle — together sharpening near-vision focus in age-related reading difficulty.

Dose & Route

1 drop / eye · Once daily (ophthalmic solution)

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Filkri

filgrastim-laha

G-CSF Biosimilar

Indication

Chemo/Radiation-induced Neutropenia

Mechanism

Signals bone marrow to produce and release white blood cells, reducing risk of severe infections after chemotherapy or radiation.

Dose & Route

SC injection or IV infusion · Weight-based dosing

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Desmoda

desmopressin acetate (oral solution)

Vasopressin Analog · Oral

Indication

Central Diabetes Insipidus

Mechanism

Mimics ADH — instructs kidneys to retain water and reduce urine output in patients with deficient hypothalamic hormone production.

Dose & Route

Oral solution · Dose individually titrated

Yuviwel

navepegritide

CNP Analog ★ First-in-Class

Indication

Achondroplasia — linear growth (children ≥2)

Mechanism

Blocks the faulty FGFR3 signal in growth-plate cartilage cells that abnormally halts bone lengthening, allowing more normal skeletal growth.

Dose & Route

SC injection · Once weekly

Adquey

difamilast 1%

Topical PDE-4 Inhibitor ★ First-in-Class

Indication

Mild-to-moderate Atopic Dermatitis (≥2 yrs)

Mechanism

Inhibits PDE-4 in skin cells, preventing breakdown of cAMP — reducing immune overactivation that causes eczema.

Dose & Route

1% ointment · Applied to affected skin · Twice daily

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Loargys

pegzilarginase-nbln

Recombinant Arginase ERT

Indication

Arginase 1 Deficiency (Hyperargininemia)

Mechanism

Replaces absent arginase-1 enzyme that breaks down arginine, preventing toxic arginine accumulation that injures the nervous system and muscles.

Dose & Route

IV infusion · Once weekly

Icotyde

icotrokira

Oral IL-23R Antagonist ★ First-in-Class

Indication

Moderate-to-severe Plaque Psoriasis (adults)

Mechanism

First oral agent to directly block the IL-23 receptor on immune cells — shutting down the inflammatory cascade driving plaque formation.

Dose & Route

Tablet 25 mg · Orally once daily

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Lynavoy

linerixibat

IBAT Inhibitor ★ First-in-Class

Indication

Cholestatic Pruritus · Primary Biliary Cholangitis

Mechanism

Blocks the gut IBAT protein that recycles bile acids back into blood — trapping bile in the bowel and reducing the liver/skin overload causing relentless itching.

Dose & Route

Tablet · Orally twice daily

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Lifyorli

relacorilan

Selective GCR Modulator

Indication

Platinum-resistant Ovarian Cancer (+ nab-paclitaxel)

Mechanism

Blocks the glucocorticoid receptor in ovarian cancer cells, stripping the tumour of cortisol-driven protection and restoring sensitivity to chemotherapy.

Dose & Route

Oral capsule · Once daily (weight-based dose)

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Avlayah

tividenofusp alfa-eknm

Brain-Penetrating I2S ERT

Indication

Hunter Syndrome — MPS Type II (all ages)

Mechanism

Delivers missing iduronate-2-sulfatase across the blood-brain barrier to break down complex sugar chains that accumulate in all organs including the brain.

Dose & Route

IV infusion · Once weekly

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Kresladi

marnetegragene autotemcel

HSC Gene Therapy ★ First-in-Class

Indication

Leukocyte Adhesion Deficiency-I (LAD-I) in children

Mechanism

Autologous stem cells corrected with a functional CD18 gene — permanently restoring the ability to fight infection with a single infusion.

Dose & Route

Single IV infusion · One-time gene therapy

Awiqli

insulin icodec-abae

Ultra-Long Basal Insulin ★ First-in-Class

Indication

Type 2 Diabetes Mellitus (adults)

Mechanism

First once-weekly basal insulin. Engineered with reversible albumin binding that keeps it active for 7 full days from a single injection.

Dose & Route

SC injection · Once weekly · Starting 70 units

Foundayo

orforgliprion

Non-Peptide Oral GLP-1 RA ★ First-in-Class

Indication

Obesity / Overweight with comorbidities (adults)

Mechanism

First non-peptide oral GLP-1 agonist. Small molecule pill activating GLP-1R — making the brain feel full sooner, slowing the stomach, reducing calorie intake. No food timing restrictions.

Dose & Route

Oral tablet · Once daily · Titrate 3 mg → 36 mg