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Nintedanib Soft Capsules
Nintedanib Soft Capsules is a Small molecule drug developed by Guangdong Hengrui Pharmaceutical Co., Ltd. It is currently in Phase 1 development.
Nintedanib is a small molecule medication used to study various conditions, including COVID-19, in clinical trials. It is available in capsule form, with dosages including 25 mg and 100 mg, and is manufactured by Boehringer Ingelheim.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Nintedanib Soft Capsules |
|---|---|
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON) (PHASE3)
- A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood (PHASE1)
- Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects (PHASE1)
- Nintedanib for Improving Reproductive Outcomes in Adenomyosis (PHASE3)
- Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease. (PHASE2)
- A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis (PHASE3)
- A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD) (PHASE3)
- A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nintedanib Soft Capsules CI brief — competitive landscape report
- Nintedanib Soft Capsules updates RSS · CI watch RSS
- Guangdong Hengrui Pharmaceutical Co., Ltd portfolio CI
Frequently asked questions about Nintedanib Soft Capsules
What is Nintedanib Soft Capsules?
Who makes Nintedanib Soft Capsules?
What development phase is Nintedanib Soft Capsules in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing