Grazax-R — Competitive Intelligence Brief

Grazax-R (Grazax-R) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Sublingual immunotherapy (SLIT). Area: Immunology / Allergy.

phase 3 Sublingual immunotherapy (SLIT) Grass pollen allergen (timothy grass, Phleum pratense) Immunology / Allergy Biologic

Target snapshot

Grazax-R (Grazax-R) — ALK-Abelló A/S. Grazax-R is an oral immunotherapy that desensitizes the immune system to grass pollen allergens through gradual exposure under the tongue.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Grazax-R TARGET	Grazax-R	ALK-Abelló A/S	phase 3	Sublingual immunotherapy (SLIT)	Grass pollen allergen (timothy grass, Phleum pratense)
sublingual allergen extract	sublingual allergen extract	Medical University of Lodz	marketed	Sublingual immunotherapy (SLIT)
immunotherapy Staloral	immunotherapy Staloral	Medical University of Silesia	marketed	Sublingual immunotherapy (SLIT)
HDM SLIT-tablet (12 SQ-HDM)	HDM SLIT-tablet (12 SQ-HDM)	ALK-Abelló A/S	phase 3	Sublingual immunotherapy (SLIT) tablet
Slit One ragweed	Slit One ragweed	ASST Fatebenefratelli Sacco	phase 3	Sublingual immunotherapy (SLIT)	Ragweed allergen (Amb a 1 and related epitopes)
Pangramin SLIT HDM mix.	Pangramin SLIT HDM mix.	ALK-Abelló A/S	phase 3	Sublingual immunotherapy (SLIT)
HDM SLIT-tablet	HDM SLIT-tablet	ALK-Abelló A/S	phase 3	Sublingual immunotherapy (SLIT) tablet

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Sublingual immunotherapy (SLIT) class)

1. ALK-Abelló A/S · 2 drugs in this class
2. ASST Fatebenefratelli Sacco · 1 drug in this class
3. HAL Allergy · 1 drug in this class
4. Medical University of Lodz · 1 drug in this class
5. Medical University of Silesia · 1 drug in this class