Nerandomilast Philippines: Three Hospitals Listed

Nerandomilast Philippines trial plans now list three hospitals and a target of twelve participants. Recruitment is still pending. The study asks whether a drug already used for lung fibrosis can also slow systemic sclerosis across more than one organ.^[1][2][4][7]

The nerandomilast Philippines trial plan appears in a 1 September entry in HERDIN, the Philippine health-research registry. It describes Boehringer Ingelheim’s local plans for a Phase 3 systemic-sclerosis study. It names Philippine General Hospital, Ospital ng Makati and Manila Doctors Hospital, with the local project planned to start on 15 September 2026.^[1][2]

The study is VERANDA-SSc, NCT07497087, with a target of 448 participants worldwide. Its international record already lists a July start. The Philippine filing therefore adds local plans to a programme already under way.^[3][4]

Witfire’s focus here is the primary endpoint: death or disease progression, rather than a breathing test alone. For an oral antifibrotic medicine, that is a broader benefit to demonstrate.^[1]

01 Nerandomilast Philippines: what the filing establishes

Philippine registry ID

PHRR260831-010579

Local sponsor

Boehringer Ingelheim (Philippines), Inc.

Local target

12 participants; actual recruitment not specified

Project dates

15 September 2026 to 15 September 2030

Recruitment / project status

Pending / Ongoing

Sources ^[1][2]

HERDIN lists project activity and recruitment separately. The project can be marked “Ongoing” while recruitment remains “Pending”. The record gives no usable date for first enrolment.^[1][2]

A hospital’s registry entry tells us where research is planned; a confirmed enrolment tells us someone has joined. In a placebo-controlled trial, neither tells us that person received the active drug. Witfire’s PULSE-LHD report makes the same distinction when reading a first-patient announcement.

Which Philippine sites will start recruiting, and when? That is the immediate question. The scheduled date gives us a point to check, but it does not tell us a first dose has been given.

02Twelve participants within a 448-person study

Even if every planned Philippine place is filled, the country group will be too small to support a reliable, stand-alone claim of effectiveness in Filipino patients. The main conclusion will have to come from the multinational comparison. That should guide how the results are reported.

The nerandomilast Philippines target cannot simply be divided into four participants per hospital. No site-by-site allocation is published in the filing, and some hospitals could recruit more participants than others.^[1]

Philippine participation brings local investigators and selected patients into the study. Its value will be clearer once we know who enrolled, how their disease compares with the wider population and whether follow-up was complete. A list of hospitals cannot tell us that.

03The drug already has evidence, but for lung fibrosis

Systemic sclerosis affects patients differently. It can thicken the skin and damage internal organs, with blood-vessel disease and immune dysfunction alongside fibrosis. Lung involvement is part of that picture; the digestive tract and circulation can also be affected.^[9]

In the United States, nerandomilast is sold as Jascayd. The FDA approved it for idiopathic pulmonary fibrosis on 7 October 2025, then for progressive pulmonary fibrosis on 19 December 2025. Those remain the two indications on the current U.S. label.^[5][6][7]

A patient with systemic sclerosis may also develop progressive pulmonary fibrosis, so there is overlap between the conditions. But treating lung fibrosis does not, by itself, show that a medicine works against systemic sclerosis as a whole. That is the question behind VERANDA-SSc and the nerandomilast Philippines trial plan.

Nerandomilast preferentially inhibits phosphodiesterase 4B, an enzyme that helps break down the signalling molecule cAMP. Effects on inflammatory signalling and fibrotic processes form part of the reason for testing it. Preferential inhibition does not mean exclusive PDE4B activity. The biology gives the trial a rationale; it cannot take the place of clinical results.^[7][11]

04 Nerandomilast Philippines trial: what VERANDA-SSc will compare

The study assigns adults with limited or diffuse cutaneous systemic sclerosis to nerandomilast or matching placebo, taken as tablets twice daily. Disease must have begun within seven years of the first symptom other than Raynaud’s phenomenon. Participants must also meet the disease-activity and organ-function criteria.^[4]

The Philippine record specifies 18 mg twice daily. A 9 mg dose is available for individual tolerability or when strong CYP3A inhibitors are also being taken. These are the trial’s dosing provisions, not instructions for patients to start treatment or change their dose.^[1]

Primary comparison

Time to all-cause death or disease progression

Lung component

Confirmed absolute FVC decline of at least 5 percentage points of predicted value, in participants with ILD at baseline

Skin component

mRSS increase of at least 5 points and at least 25% relative to baseline

Other progression

Adjudicated, clinically meaningful SSc-related progression or complications

Week-52 secondary measures

Skin score, disability, FVC, composite response, disease impact and digital-ulcer burden

Sources ^[1][3]

Both skin conditions have to be met; either one alone is not enough. For the lungs, the threshold uses percentage points of predicted FVC, not a 5% relative fall in measured millilitres. These details can change which events count.

A composite endpoint brings different kinds of deterioration into one measure. That can leave a headline looking simpler than the result: fewer lung-function events, with little change elsewhere, would mean something different from fewer major organ complications. We need the event counts and uncertainty estimates for each component.^[12]

Including death in the nerandomilast Philippines trial endpoint does not mean that a positive composite result, on its own, proves patients lived longer.

05The earlier lung results, with both doses shown

The 2025 FIBRONEER-ILD publication reported results from 1,176 participants who received at least one dose. It compared 18 mg and 9 mg twice daily with placebo in progressive pulmonary fibrosis; 43.5% of participants were already receiving nintedanib at baseline.^[8]

18 mg versus placebo

67.2 mL difference in FVC change
95% CI 31.9 to 102.5 mL

9 mg versus placebo

81.1 mL difference in FVC change
95% CI 46.0 to 116.3 mL

Diarrhoea

18 mg: 36.6%; 9 mg: 29.5%; placebo: 24.7%

Sources ^[8]

The table uses the adjusted comparisons reported in the paper. Calculating the differences again from rounded group means can shift the last decimal slightly, so the published estimates are the ones to use.

The placebo-adjusted difference was numerically larger at 9 mg. That alone does not make 9 mg the better dose. Deciding between them would require a suitable direct comparison and a look at the wider benefit–risk evidence, rather than a ranking of two point estimates.

These results belong to the earlier progressive pulmonary fibrosis trial. They are not results from VERANDA-SSc or its nerandomilast Philippines sites. They show prior activity that gives the new study a reason to be taken seriously. Whether that extends to systemic sclerosis more broadly remains unanswered.

06The treatment has to fit care patients already receive

Participants may continue certain stable background treatments, including mycophenolate and nintedanib. Some will therefore enter the comparison already taking medicines.^[1][4]

The final report needs to make that treatment context clear. An added benefit alongside an existing therapy is not evidence that the therapy can be replaced; that needs the relevant comparison. The same question comes up in Witfire’s RENGEVITY-201 trial analysis.

Care for systemic sclerosis already follows the organs and symptoms affected. Immunosuppressive treatment, medicines that widen blood vessels and other measures do different jobs. An oral tablet would need to add enough benefit to justify its place in that treatment plan.^[10]

The current Jascayd label includes diarrhoea, reduced appetite, weight loss and depression among its adverse reactions, along with instructions on CYP3A interactions. This tells us what is known about the marketed medicine. It does not give adverse-event rates observed in VERANDA-SSc or its nerandomilast Philippines sites.^[7]

Clinicians will want to know how many participants stayed on treatment, how often their doses changed and whether the benefit helped them function better day to day. A statistically favourable curve needs a different reading if many participants stop treatment than if use is sustained.

07 Nerandomilast Philippines: what Boehringer could gain

Boehringer already operates in pulmonary fibrosis. Its 2025 results reported €3.8 billion in Ofev sales and the launch of Jascayd. That describes its existing business. It does not tell us what a systemic-sclerosis indication might earn.^[13]

For Witfire, the commercial opportunity depends on how much of the disease the drug can affect. A convincing reduction in progression beyond lung-function loss could give it a wider clinical role. Benefit concentrated in the lungs could still matter, but the case for using it would be narrower.

Even with a broader label, practical questions would remain. Who would be eligible, and what would another medicine add to their treatment costs? Would the benefit be enough for clinicians to change prescribing? The Philippine filing gives no local price, reimbursement decision or launch date.

CONQUEST needs to be kept separate. It is a Phase 2b platform study in early active systemic sclerosis with interstitial lung disease. The published design named nerandomilast and amlitelimab as the first investigational agents and FVC change at week 52 as the primary efficacy endpoint. That is a different study from VERANDA-SSc.^[11]

Results from one programme may help interpret the other, but their populations and questions are not interchangeable. Before combining findings from a company update with another study, check the trial identifier.

08Witfire Risk Score: 5.5 out of 10

This nerandomilast Philippines assessment is for the systemic-sclerosis development programme. Higher scores reflect greater uncertainty in Witfire’s judgement. The five dimensions and their weights stay fixed; the individual ratings are editorial judgements, not measured probabilities.

Scale: below 4.0 low; 4.0 to below 7.0 moderate; 7.0 to 10 elevated. This editorial index is not a probability of approval, trial failure or patient harm.

Funding is the strongest part of this nerandomilast Philippines assessment. Evidence for the new disease claim is still missing. A large sponsor can sustain a long trial, but the comparison must still show a benefit that is useful in practice.

09 Nerandomilast Philippines: the next milestones to check

• Philippine recruitment. Look for confirmation from a site or the sponsor. The scheduled project date alone is not proof that recruitment has begun.
  Pending
• Actual enrolment. Compare the numbers actually enrolled with the local and worldwide targets. A target is not a count of patients treated.
  12 / 448 targets
• Changes to the protocol. Check for changes to eligibility, endpoints or treatment rules. Interpret results against the dated protocol version.
  Version matters
• The primary result. Read the hazard ratio together with absolute event numbers, the individual components and their confidence intervals.
  Death / progression
• Patient experience. Read skin and lung measurements alongside function, treatment withdrawal and dose changes.
  Week 52 measures

The local project period ends in September 2030, while the international listing estimates study completion in March 2030. Neither promises a date for a press release. A first-participant announcement would tell us about the running of the study; comparative results would tell us about the treatment.^[1][4]

10Witfire verdict

What has changed

A Philippine registry entry now describes local participation in a Phase 3 programme.

What is still unproved

Whether nerandomilast changes systemic-sclerosis outcomes beyond the benefits already established in pulmonary fibrosis.

What would strengthen the case

A clinically useful effect with component-level support, sustained treatment use and consistent patient-reported outcomes.

What the filing cannot establish

A Philippine commercial launch, local availability, price, reimbursement or first dose.

The named hospitals and specific local target make this a Philippine development worth reporting. For the scientific story to become larger, the trial would have to show that nerandomilast does more for systemic sclerosis than the earlier lung evidence already suggests.

For now, the nerandomilast Philippines record tells us that local research is planned, recruitment remains pending and the broader treatment question is still being tested.^[1][2]

11For academics: the study question and the analysis it needs

For the nerandomilast Philippines trial, a journal-club discussion needs more than a verdict on statistical significance. Witfire proposes five questions to ask of the results. They do not imply that the sponsor has already published these analyses.

1. Which events account for the primary effect? Look at death and the different progression components separately. A frequent, less severe event can account for much of a composite result even when a rarer event matters more to patients.
2. What happens after treatment stops? The analysis needs to explain how it handles withdrawal, rescue treatment and changes in background therapy. Follow-up after discontinuation can matter especially when tolerability differs.
3. Are subgroup conclusions supported? Separate prespecified interaction tests from a significant result within one group. A small country subset is not a basis for advertising efficacy in that population.
4. Do function and symptoms support the measurements? Read skin scores and spirometry alongside disability and disease-impact outcomes. Agreement would give more support to a broad clinical interpretation.
5. How is multiplicity controlled? Check the prespecified testing hierarchy. Several favourable secondary P values do not, by themselves, prove several separate treatment benefits.

FDA guidance on multiple endpoints sets out why the components of a composite and the testing strategy need careful reading. A full appraisal will also need the eventual protocol and statistical-analysis plan.^[12]

Citation boundary: cite VERANDA-SSc for the Phase 3 trial design and the nerandomilast Philippines record for the local research plan. Use FIBRONEER-ILD separately for the earlier PPF results. The studies answer different clinical questions.

12 Nerandomilast Philippines: reader questions

What is the nerandomilast Philippines trial?

It is the Philippine part of VERANDA-SSc, NCT07497087, a Phase 3 study comparing oral nerandomilast with matching placebo in systemic sclerosis. The local filing describes the research plan.^[1][3]

Which Philippine hospitals are listed?

The filing names Philippine General Hospital, Ospital ng Makati and Manila Doctors Hospital. It sets a country target of twelve participants but does not publish how they would be allocated among the hospitals.^[1]

Has recruitment started for the nerandomilast Philippines trial?

At the 9 September 2026 review, HERDIN still listed local recruitment as pending. The planned 15 September project start does not confirm that anyone has enrolled or received treatment.^[1][2]

Who is the study intended to enrol?

Adults with limited or diffuse cutaneous systemic sclerosis, onset within seven years and the other protocol criteria. Clinical screening determines eligibility. The country target does not tell us whether places are currently available.^[4]

Is nerandomilast approved for systemic sclerosis?

The U.S. Jascayd label reviewed here covers IPF and PPF, rather than systemic sclerosis as a whole. VERANDA-SSc is testing that broader use. A trial listing does not confirm Philippine marketing approval.^[7]

What will the primary endpoint measure?

It measures time to all-cause death or disease progression, including defined complications, lung-function decline and skin worsening. A positive result for the composite alone would not prove a survival benefit.^[1][12]

Is VERANDA-SSc the same as CONQUEST?

No. CONQUEST is a separate Phase 2b platform trial in early active systemic sclerosis with ILD; its published design named nerandomilast and amlitelimab as the first agents. VERANDA-SSc is the separate Phase 3 study.^[3][11]