United Therapeutics Plans Ralinepag DPI Launch and Expansion in 2026

United Therapeutics’ perspective on MannKind’s Ralinepag dry powder inhalation (DPI) program

Based on United Therapeutics’ 2026 Q1 earnings call commentary, UT views MannKind’s DPI (dry powder inhalation) contribution for ralinepag as both (a) execution-proven and (b) strategically necessary to extend UT’s inhaled prostacyclin franchise—especially Tyvaso—into additional pulmonary indications (IPF, PH-ILD/ILD, and PAH) while reinforcing UT’s “multiple shots on goal” approach.

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1) UT’s qualitative stance: “excited” to work with MannKind again; expects an “even better encore”

UT explicitly states it is “excited to work with the MannKind development team again,” describing prior collaboration on Tyvaso DPI as “nothing short of incredible,” and stating UT “expect[s] an even better encore with RALDPI.” ¹²

They further quantify progress on the ralinepag DPI program (RALDPI) as of the call:

• UT began work on RALDPI “about 6 months ago” and says it has made “great progress” including “completion of formulation development” and “transition into manufacturing tox study supplies.” ²
• UT says it had a “very positive pre-IND engagement with FDA,” will move into “minimal nonclinical testing,” followed by “an IND in a Phase I study,” which UT “believe[s]” will be completed “before the end of the year.” ²³

Interpretation: UT’s tone and timeline imply confidence that MannKind’s platform for DPI execution is a workable manufacturing/formulation pathway, not a speculative technology trial. ²

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2) Product/technology fit: UT will use MannKind’s “crystal carrier IP” for ralinepag, “not a prodrug”

UT states it will “leverage MannKind’s crystal carrier IP for ralinepag,” and emphasizes that it “is not going to be a prodrug.” ⁴

UT also positions the initial approach as “very similar formulation to the current treprostinil in using MannKind’s crystal carrier IP,” while noting it may investigate other ralinepag polymorphs in the future. ⁴

Financial/strategic implication: UT is treating MannKind’s DPI enabling technology as a proven formulation pattern (akin to what was done for treprostinil), which can reduce development friction and support faster regulatory and launch planning—important because UT repeatedly ties its future growth to sequential approvals and rapid market penetration. ⁴⁵⁶

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3) UT’s conviction on ralinepag DPI’s clinical/treatment impact (and why that matters for Tyvaso)

3.1 UT believes ralinepag DPI (RALDPI) can expand the prostacyclin addressable market

UT argues that ralinepag (as RALDPI) has the potential to “revolutionize” PAH treatment and potentially shift the treatment paradigm toward earlier prostacyclin use “in conjunction with ERAs and PDE-5s.” ⁵

UT also claims ralinepag is a “first true once-a-day oral prostacyclin agonist” and frames the ADVA NCE OUTCOMES results as “unprecedented top line results.” ⁵

3.2 UT frames the positioning: “coming right behind Tyvaso for IPF”

UT describes a near-term IPF sequence for inhaled therapies:

• “coming right behind Tyvaso for IPF will be Tyvaso DPI for IPF and right behind that, Tyvaso SMI for IPF.” ¹
• UT then positions “RALDPI” as the next “blockbuster product” emerging from stealth mode, with an anticipated large patient footprint across PAH/ILD/IPF/PPF. ¹

Interpretation: UT does not appear to view ralinepag DPI as an isolated product; rather, it is treated as part of a staged portfolio rollout where Tyvaso remains the lead to expand coverage first, then ralinepag DPI adds additional efficacy/delivery options later—supporting Tyvaso franchise durability while increasing overall prostacyclin share. ¹⁶

3.3 UT believes delivery/device options are patient-specific (“Snowflakes”)

UT emphasizes that patients respond differently to drug-delivery approaches and device types, stating:

• “patients are like Snowflakes” and there is a “role for all of these products in PAH,” mirrored for IPF via “multiple shots on goal.” ⁷
• UT also notes a population dynamic: oral convenience is appealing, but systemic vasodilators may be contraindicated in PH-ILD/IPF due to V/Q mismatch risk, and therefore “inhaled would be more for this other population.” ⁸
• On delivery format within inhaled therapy: UT states “some patients… might be more sensitive to the powder versus the nebulizer,” which supports having both DPI and nebulized options. ⁸

Financial implication: UT’s rationale supports ralinepag DPI as a way to capture incremental patients for whom DPI is preferable or clinically optimal, which can help preserve and grow Tyvaso-related demand rather than purely cannibalize it. ⁷⁸

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4) Timing and regulatory strategy: fast Phase I completion; bridge strategy for DPI in IPF; ralinepag likely first in PAH

UT ties the overall development plan to speed and sequencing:

4.1 RALDPI Phase I timing and next steps

UT expects:

• completion of the “initial Phase I study” “by the end of the year” and then rapid kickoff of efficacy studies in “PAH… as well as PH-ILD, IPF and PPF,” with “PAH” initially being first. ³

4.2 IPF regulatory bridging for Tyvaso DPI (and by extension a portfolio delivery pathway)

UT states it is “working with FDA to come up with our bridging strategy for IPF with the Tyvaso DPI,” likely including “healthy volunteer PK compatibility studies,” “comparability studies,” and “patient studies” to demonstrate safety and efficacy. ⁹

UT also states the regulatory pathway should be “as expected,” specifically:

• “nebulized approved in IPF,” then “whatever agreed upon bridging study is necessary,” then “proceed directly with the filing.” ¹⁰

How this relates to ralinepag DPI impact on Tyvaso/IPF/PAH/IPF-related IP:

• UT’s statements suggest it expects regulatory friction to be manageable because it has already established (or is establishing) a bridging model for DPI within IPF. ⁹¹⁰
• UT’s commentary repeatedly ties future growth to multiple inhaled formulations across diseases, which implies the “IP impact” is less about a single patent argument in the excerpt and more about maintaining control/advantage via device-formulation IP (MannKind crystal carrier IP) combined with UT’s own IP and clinical positioning. ⁴¹

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5) Market impact: UT expects large treated-patient volumes for ralinepag DPI and capacity planning (suggesting confidence in demand pull)

UT foresees ralinepag DPI reaching “tens of thousands of treated patients through PAH, ILD, IPF and PPF,” and explicitly says it “will need all the capacity” of:

• “the Danbury, Connecticut MannKind production plant,” and
• “all the capacity of the new United Therapeutics North Carolina DPI facility” to keep up with “Tyvaso DPI and RALDPI demand.” ¹

Interpretation: UT’s capacity planning is a strong signal of expected commercial scale and reliance on MannKind’s manufacturing capacity for DPI supply—meaning UT views MannKind’s Ralinepag DPI program as directly tied to Tyvaso DPI’s demand continuity and to the ramp of RALDPI. ¹

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Bottom line: UT’s perspective on MannKind’s ralinepag DPI program and potential impact

1. Execution confidence: UT is optimistic and already operationally engaged, citing rapid progress (formulation/tox supplies), positive FDA engagement, and a Phase I completion target before year-end. ²³
2. Technology validation: UT plans to use MannKind’s crystal carrier DPI IP for ralinepag “not” as a prodrug and expects formulation approach similarity to treprostinil DPI, which UT likely views as lowering development and device risk. ⁴
3. Portfolio role vs. Tyvaso: UT frames Tyvaso therapies as the leading backbone for IPF delivery and positions ralinepag DPI (RALDPI) as a major subsequent “blockbuster” that can expand treated patients across PAH and IPF-adjacent indications, with a patient-specific role for DPI vs nebulizer. ¹⁷⁸
4. Commercial scaling and supply-chain linkage: UT explicitly plans to use MannKind production capacity to meet combined Tyvaso DPI and RALDPI demand, implying UT sees a meaningful incremental revenue stream and demand generation from DPI adoption. ¹

In short, UT treats MannKind’s ralinepag DPI program as a credible, scalable, and strategically important component of UT’s inhaled prostacyclin franchise—expected to broaden patient access and expand impact in PAH and IPF/PH-ILD, while Tyvaso remains the foundational therapy in IPF during the staged rollout. ¹⁶⁷⁸