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Upacicalcet meets primary endpoint in two Phase 3 trials for dialysis patients

Upacicalcet meets primary endpoint in two Phase 3 trials for dialysis patients

New Capabilities

Pathalys Pharma's IV calcimimetic cut parathyroid hormone; an FDA filing is next, with no date set

October 26th, 2026: EA Pharma confirms US Phase 3 results for its discovered drug

Overview

Updated Nov 2

Nearly all dialysis patients develop secondary hyperparathyroidism, a condition where parathyroid hormone rises out of control and raises the risk of bone fractures and heart disease. On October 23, Pathalys Pharma reported that its intravenous drug upacicalcet cut parathyroid hormone by at least 30% in 42% of treated patients, against 17% on placebo, in two identical Phase 3 trials.

The Journal of the American Society of Nephrology published both trials the same day. On October 26, EA Pharma, the Japanese company that discovered upacicalcet, said its partner had presented the US results. Pathalys has not set a date for its FDA filing; upacicalcet has been sold in Japan since 2021.

Why it matters

US dialysis patients have had no new IV calcimimetic since 2017, and this one is still unapproved here.

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Key Indicators

42.1%
PATH-1 primary endpoint rate
Patients on upacicalcet cutting PTH by 30% or more, versus 16.8% on placebo.
43.5%
PATH-2 primary endpoint rate
Same endpoint in the second trial, versus 17.4% on placebo.
27.2%
PTH cut by half, PATH-1
Share of upacicalcet patients halving PTH, versus 7.5% on placebo.
768
Patients across both trials
Randomized 2:1 to upacicalcet or placebo after each dialysis session for 27 weeks.
31%
Low calcium, PATH-1
Corrected calcium under 7.5 mg/dl with upacicalcet, versus 12% on placebo; symptomatic cases were rare.

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People Involved

Jessica Kendrick, MD, MPH
Jessica Kendrick, MD, MPH
Professor of renal medicine, University of Colorado; primary investigator for PATH trials
Presented the Phase 3 findings at ASN Kidney Week 2026
 Bastian Dehmel, MD
Bastian Dehmel, MD
Chief Medical Officer, Pathalys Pharma
Leads clinical development for upacicalcet

Organizations Involved

Pathalys Pharma
Pathalys Pharma
Private biopharmaceutical company
Developing upacicalcet for US approval; presented Phase 3 data at ASN Kidney Week 2026 and has not set an FDA filing date

Private US biopharmaceutical company developing upacicalcet for chronic kidney disease.
American Society of Nephrology
American Society of Nephrology
Medical society
Hosted Kidney Week 2026 and published trial results in its journal

Medical society that hosted Kidney Week 2026 and publishes the Journal of the American Society of Nephrology.
EA Pharma
EA Pharma
Pharmaceutical company
Discovered upacicalcet; sells it in Japan as Upasita and partners with Pathalys on US development

Japanese drugmaker that discovered upacicalcet and markets it in Japan as an IV injection for dialysis patients.

Timeline

2021 October 2026

5 events Latest: October 26th, 2026 · 2 weeks ago
Tap a bar to jump to that date

  1. EA Pharma confirms US Phase 3 results for its discovered drug

    Latest Corporate

    EA Pharma, which discovered upacicalcet and sells it in Japan as Upasita, said partner Pathalys presented favorable US Phase 3 results.

  2. PATH-1 and PATH-2 results presented

    Clinical Results

    Both pivotal US trials meet primary and key secondary endpoints; papers published in JASN.

  3. Biomarker poster reports FGF23 and bone-turnover reductions

    Clinical Results

    A separate Kidney Week poster reported lower iPTH, whole PTH and FGF23, plus changes in three bone-turnover markers, across the PATH-1 and PATH-2 populations.

  4. Japanese Phase 3 data published

    Publication

    A 24-week placebo-controlled trial in Japanese dialysis patients shows PTH reductions.

  5. Japan approves upacicalcet

    Regulatory Approval

    Japanese regulators clear upacicalcet for SHPT in dialysis patients.

Scenarios

1

FDA approves upacicalcet for SHPT

Likely Resolves by End of 2028

Discussed by: Pathalys leadership and trial investigators

Pathalys files a New Drug Application with the FDA and the agency approves upacicalcet for secondary hyperparathyroidism in hemodialysis patients, making it the first new calcimimetic in nearly a decade. The two positive trials, with similar effect sizes and tolerable safety, support a standard review.

2

FDA issues Complete Response Letter, delaying approval

Possible Resolves by End of 2028

Discussed by: FDA precedent and trial safety data

The FDA asks for more data before deciding, whether on asymptomatic hypocalcemia, which reached 23% versus 8% on placebo in PATH-1, or on manufacturing. Upacicalcet is already approved in Japan, but the agency has required additional US trials for other calcimimetics when safety questions emerged.

3

Pathalys is acquired or partners on upacicalcet

Uncertain Resolves by End of 2027

Discussed by: Biotech industry observers

A larger pharmaceutical company acquires Pathalys or licenses US rights to upacicalcet after the Phase 3 success. Single-asset companies with positive pivotal data often attract buyers seeking to add a CKD product to their portfolios, which would change who carries the drug through approval and launch.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

March 2004

Cinacalcet (Sensipar), 2004

Amgen's cinacalcet became the first calcimimetic approved by the FDA. The oral pill lowered PTH in dialysis patients but its gastrointestinal side effects and daily dosing limited how widely it was used.

Then

Cinacalcet became the standard medical treatment for SHPT.

Now

Its patent has since expired and generics are available, so new entrants must compete on dosing and safety rather than novelty.

Why this matters now

Upacicalcet enters a market where the oral calcimimetic is generic and cheap, so its value rests on the IV route and side-effect profile.

February 2017

Etelcalcetide (Parsabiv), 2017

Amgen's etelcalcetide, approved in 2017, was the first intravenous calcimimetic, dosed three times weekly after dialysis. It proved the injectable approach works but carried its own hypocalcemia and gastrointestinal risks.

Then

Etelcalcetide offered an alternative for patients who could not tolerate oral cinacalcet.

Now

It set the precedent that IV calcimimetics are viable for this population, but also established expectations about managing hypocalcemia.

Why this matters now

Upacicalcet follows the same IV model nearly a decade later, aiming to improve on the established safety profile.

Sources

(6)
Pathalys Pharma American Society of Nephrology NephJC Journal of the American Society of Nephrology EA Pharma Lonevi